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    Curia Boosts Glasgow Manufacturing And Cell Line Development

    19 Mar 2026

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    Curia Releases 2024 Environmental, Social and Governance Report

    28 Oct 2025

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    Curia Invests $4 Million To Enhance Sterile API Manufacturing

    27 Oct 2025

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    Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    26 Corporate Circle, Albany, New York 12203
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    Sales Offices: 

    ITALY

    Rozzano - Quinto de’ Stampi

    Via Volturno, 41/43

    20089 - Rozzano (MI) - Italy

    Tel: +39 02 822 72 1

     

    SPAIN

    Parque Tecnológico, Parcela 105

    47151 Boecillo, Valladolid, Spain

    Tel: +34 983 54 80 72

     

    JAPAN

    Level 28 Shinagawa Intercity Tower A

    2-15-1 Konan Minato-ku

    Tokyo 108-6028, Japan

    Tel: +81 3 6717 2807 

     

    CHINA

    Shanggu Commercial Center A-601

    Tian Ta Street, Nankai District

    Tianjin 300381, China

    Tel: +86 22 23412321

     

    INDIA

    713, Exim Link Building

    Opp. Indira Container Yard

    Mulund – Goregoan Link Road, Nahur (W)

    Mumbai – 400078, India

    Tel: 022 67250230-31 

     

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    UNITED STATES

    RENSSELAER

    33 Riverside Avenue

    Rensselaer, New York 12144 USA

     

    ALBANY

    21 Corporate Circle

    Albany, New York 12203 USA

     

    GRAFTON

    870 Badger Circle

    Grafton, Wisconsin 53024 USA

     

    SPRINGFIELD

    2460 West Bennett Street

    Springfield, Missouri 65807 USA

     

    FRANCE

    BON ENCONTRE

    Zone Industrielle de Laville

    F-47240 - Bon-Encontre - France

     

    TONNEINS

    Avenue du Dr Nicole Bru

    F-47400 - Tonneins - France

     

    GERMANY

    FRANKFURT

    Industriepark Höchst

    65926 - Frankfurt - Germany

     

    ITALY

    ROZZANO - Quinto de’ Stampi

    Via Volturno, 41/43

    20089 - Rozzano (MI) - Italy

    ROZZANO - Valleambrosia

    Via Monterosa, 114

    20089 - Rozzano (MI) - Italy

    ORIGGIO

    Viale Europa, 5

    21040 - Origgio (VA) - Italy

     

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    Parque Tecnológico, Parcela 105

    47151 Boecillo, Valladolid, Spain 

     

    INDIA

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    Curia India Pvt. Ltd.

    G-1/1, 1/2, MIDC Area

    Waluj, Aurangabad 431 136

    (Maharashtra), India

     

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    Finkem Laboratories Pvt. Ltd.

    G-39/5, MIDC Area

    Waluj, Aurangabad 431 136

    (Maharashtra), India

     

     

     

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    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    PharmaCompass is introducing a new regulatory update that tracks developments in Certificates of Suitability to the Monographs of the European Pharmacopoeia, referred to as CEPs. These certificates are a critical regulatory instrument in the global pharmaceutical supply chain.Also known as a Certification of Suitability (COS), CEPs are issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM), with or without inspection of the manufacturing site. A CEP must be renewed every five years from its original issue date to remain valid, regardless of any revisions made during the interim period. However, a CEP does not replace Good Manufacturing Practice certification.CEPs are recognized as a trusted reference for API quality, thereby simplifying global registration strategies. Apart from Europe, the CEP system is widely used by many regulatory authorities, including those in Canada, Australia, Brazil, Singapore and South Africa. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)CEP 2.0 enhances regulatory clarity, brings efficiency, global interoperability There are several types of CEPs, depending on the nature of the substance and evaluation. The most common type is the Chemical CEP, which confirms that a chemically synthesized API meets standards for purity and impurity control. Then there are Herbal CEPs for herbal substances and preparations.Another key category is the TSE CEP, which addresses risks associated with transmissible spongiform encephalopathies in animal-derived materials. In addition, there are Combined CEPs that may cover multiple aspects, such as chemical quality, TSE risk, and sterility. However, biological products such as vaccines and blood products fall outside the scope of the CEP framework.In 2023, the CEP system underwent a major transformation with the introduction of CEP 2.0, which marks a shift from a largely document-based system to a more structured, transparent, and digitally aligned model. This makes it easier for companies to manage compliance while improving trust among global regulators.While increasing data and compliance requirements for API manufacturers, CEP 2.0 enables better regulatory clarity, streamlined dossier integration, and stronger global acceptance. Overall, CEP 2.0 is designed to enhance regulatory clarity while making the system more efficient and globally interoperable. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Indian firms issued maximum CEPs; Sun Pharma and its subsidiaries, Jubilant Biosys top listIndia topped the charts for CEPs issued, both in terms of new CEPs and revisions in the first quarter (Q1) of 2026. Indian companies were issued 81 new CEPs in Q1 2026 (as against 40 in Q1 2025) and 203 revisions (as against 129 in Q1 2025). In comparison, Chinese companies were issued 42 new CEPs in Q1 2026 (against 25 in Q1 2025) and 53 revisions (against 67 in Q1 2025). Italy came a distant third, followed by Germany and Spain.India’s Sun Pharmaceuticals and its subsidiaries topped the list of companies with the maximum number of CEPs issued— while no new CEP was issued, 27 CEPs were revised in Q1 2026. At second place was Jubilant Biosys — 21 CEPs were revised in Q1 2026.In terms of products, the maximum CEPs were issued for amlodipine besylate (a calcium channel blocker used for treating hypertension), followed by sitagliptin phosphate (a type 2 diabetes medicine) and pregabalin (a drug used to treat neuropathic pain, fibromyalgia, seizures, and generalized anxiety disorder). Both amlodipine besylate and sitagliptin phosphate had not been issued new CEPs or revisions in Q1 2025. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)EDQM introduces new guidelines to accelerate CEP assessments The EDQM charges fees for various services related to CEPs that depend on the type of request or regulatory activity involved. In general, fees apply to handling CEP applications, revisions or renewals and for offering technical advice (where applicants seek scientific or regulatory guidance).In March 2026, the EDQM introduced two new guidelines aimed at accelerating CEP assessments. The first is a reliance-based assessment pathway, which allows regulators to leverage prior approvals from trusted authorities, such as those in the EU, UK, Australia, Canada, and the WHO pre-qualification program. The second is a fast-track assessment route designed to expedite reviews in situations such as medicine shortages and to support initiatives like the EU Critical Medicines Act.Timelines have been significantly compressed under these new pathways. Initial evaluations are completed within 46 working days, compared to up to 115 days under the standard procedure. Applicants are given 30 calendar days to respond to queries, after which regulators complete the final assessment within 23 working days.Another important regulatory update relates to electronic submissions. From April 1, 2026, the EDQM will reject non-compliant CEP applications at the point of submission. All applications must include a validated electronic Common Technical Document (eCTD) dossier along with a proper validation report, submitted in line with the updated Common European Submission Portal (CESP) guidelines. Taken together, these developments signal a more rigorous yet efficient CEP ecosystem. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Our viewThe shift to CEP 2.0 signals a move toward greater transparency, digitalization, and global regulatory alignment. Though enhanced disclosure and stricter e-submission requirements may increase the compliance burden, especially for smaller manufacturers, the long-term gains are expected to be significant. Going forward, companies that invest in data quality and regulatory readiness stand to gain from these changes.
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    #PharmaFlow by PHARMACOMPASS
    09 Apr 2026
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    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 
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    #PharmaFlow by PHARMACOMPASS
    13 Nov 2025
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    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    #PharmaFlow by PHARMACOMPASS
    19 Dec 2024
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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    #PharmaFlow by PHARMACOMPASS
    08 Aug 2024
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    Curia Boosts Glasgow Manufacturing And Cell Line Development
    Curia Boosts Glasgow Manufacturing And Cell Line Development

    19 Mar 2026

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/curia-expands-glasgow-manufacturing-capacity-and-enhances-cell-line-development-platform/

    PRESS RELEASE
    19 Mar 2026
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    Curia Releases 2024 Environmental, Social and Governance Report
    Curia Releases 2024 Environmental, Social and Governance Report

    28 Oct 2025

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/curia-releases-2024-environmental-social-and-governance-esg-report/

    PRESS RELEASE
    28 Oct 2025
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    Curia Invests $4 Million To Enhance Sterile API Manufacturing
    Curia Invests $4 Million To Enhance Sterile API Manufacturing

    27 Oct 2025

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/curia-invests-4-million-to-enhance-sterile-api-manufacturing/

    PRESS RELEASE
    27 Oct 2025
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    CDMO Leadership Announcement
    CDMO Leadership Announcement

    01 Apr 2025

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/cdmo-leadership-announcement/

    PRESS RELEASE
    01 Apr 2025
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    Curia Expands Global Sterile Fill-Finish Network
    Curia Expands Global Sterile Fill-Finish Network

    17 Mar 2025

    // PRESS RELEASE

    https://curiaglobal.com/about-us/news/curia-announces-expansions-to-global-network-of-sterile-fill-finish-sites/

    PRESS RELEASE
    17 Mar 2025
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    Curia Refinances Senior Secured Credit Facilities
    Curia Refinances Senior Secured Credit Facilities

    10 Mar 2025

    // CONTRACTPHARMA

    https://www.contractpharma.com/breaking-news/curia-refinances-senior-secured-credit-facilities/

    CONTRACTPHARMA
    10 Mar 2025
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    ALL APIs

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    01

    Betamethasone Dipropionate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-05

    Pay. Date : 2015-09-24

    DMF Number : 17046

    Submission : 2003-12-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-031 - Rev 03

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 809

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10367

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2007-12-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0009

    Start Marketing Date : 1984-10-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT arrow-down
    Company Banner

    02

    Betamethasone Sodium Phosphate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-12-07

    Pay. Date : 2023-09-27

    DMF Number : 38831

    Submission : 2023-09-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-032 - Rev 01

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 810

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10235

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2007-07-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0004

    Start Marketing Date : 1965-03-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF CN, RU arrow-down
    ✖
    Available Reg. Filing : CN, RU
    AUDIT arrow-down
    Company Banner

    03

    Clobetasol Propionate

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26191

    Submission : 2012-06-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-095 - Rev 02

    Issue Date : 2025-04-28

    Type : Chemical

    Substance Number : 2127

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10016

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2010-01-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0003

    Start Marketing Date : 1994-02-16

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Donggoo Biopharmaceutical Co., Ltd.

    Registration Date : 2011-05-16

    Registration Number : 20080530-93-E-56-03(1)

    Manufacturer Name : Curia Spain SAU

    Manufacturer Address : Parque Tecnologico de Boecillo, Parcela 105, 47151- Boecillo (Valladolid)

     VMF Others AUDIT arrow-down
    Company Banner

    04

    Cyclosporine

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-16

    Pay. Date : 2013-12-02

    DMF Number : 12949

    Submission : 1998-04-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-034 - Rev 06

    Issue Date : 2021-08-30

    Type : Chemical

    Substance Number : 994

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10617

    Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy

    Initial Date of Registration : 2006-07-03

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55486-1604

    Start Marketing Date : 2021-11-04

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : AbbVie Korea

    Registration Date : 2015-06-18

    Registration Number : 20150618-18-C-338-07

    Manufacturer Name : Curia Italy Srl

    Manufacturer Address : Via Volturno, 41/43 - 20089 ROZZANO (MI), Italy

     VMF CN arrow-down
    ✖
    Available Reg. Filing : CN
    AUDIT arrow-down
    Company Banner

    05

    Dorzolamide Hydrochloride

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-21

    Pay. Date : 2013-09-11

    DMF Number : 18385

    Submission : 2005-05-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-115 - Rev 04

    Issue Date : 2025-07-22

    Type : Chemical

    Substance Number : 2359

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10011

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2015-01-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0039

    Start Marketing Date : 1994-12-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2023-01-06

    Registration Number : 20211115-209-J-1151(B)

    Manufacturer Name : CURIA SPAIN SAU

    Manufacturer Address : Parque Tecnológico de Boecillo, Parcela 105. 47151 Boecillo, Valladolid, Spain

     VMF Others AUDIT arrow-down
    Company Banner

    06

    Furosemide

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-23

    Pay. Date : 2016-02-23

    DMF Number : 30288

    Submission : 2016-02-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-069 - Rev 09

    Issue Date : 2021-08-09

    Type : Chemical

    Substance Number : 391

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0222

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 70193-0002

    Start Marketing Date : 1983-11-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT arrow-down
    Company Banner

    07

    Hydrocortisone

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-01-07

    Pay. Date : 2018-09-18

    DMF Number : 33002

    Submission : 2018-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-045 - Rev 02

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 335

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10680

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65089-0061

    Start Marketing Date : 2021-07-20

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Company Banner

    08

    Minocycline Hydrochloride

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-16

    DMF Number : 14802

    Submission : 2000-03-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-107 - Rev 10

    Issue Date : 2024-02-27

    Type : Chemical

    Substance Number : 1030

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10699

    Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44657-0081

    Start Marketing Date : 2019-10-31

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (30kg/30kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Company Banner

    09

    Flutamide

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12807

    Submission : 1997-12-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-049 - Rev 07

    Issue Date : 2024-09-10

    Type : Chemical

    Substance Number : 1423

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 44657-0048

    Start Marketing Date : 2012-03-28

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    10

    Pancuronium Bromide

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16052

    Submission : 2002-07-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-120 - Rev 05

    Issue Date : 2025-10-22

    Type : Chemical

    Substance Number : 681

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55486-1568

    Start Marketing Date : 2012-06-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Alclometasone Dipropionate

    U.S.A
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    Curia

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16871

    Submission : 2003-09-29

    Status : Active

    Type : II

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    02

    Altrenogest

    U.S.A
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    Curia

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28843

    Submission : 2014-11-26

    Status : Active

    Type : II

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    03

    Amphetamine Aspartate

    U.S.A
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    Curia

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16020

    Submission : 2002-06-21

    Status : Active

    Type : II

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    04

    Amphetamine Aspartate, Monohydrate D...

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    Curia

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-01-03

    Pay. Date : 2013-11-21

    DMF Number : 17692

    Submission : 2004-09-22

    Status : Active

    Type : II

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    05

    Amphetamine Sulfate Usp

    U.S.A
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    Curia

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-01-03

    Pay. Date : 2013-11-21

    DMF Number : 16019

    Submission : 2002-06-21

    Status : Active

    Type : II

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    06

    Argatroban

    U.S.A
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    Curia

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-11-18

    Pay. Date : 2013-10-25

    DMF Number : 20760

    Submission : 2007-08-07

    Status : Active

    Type : II

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    07

    Argatroban Monohydrate

    U.S.A
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    Curia

    GDUFA

    DMF Review : Complete

    Rev. Date : 2024-10-15

    Pay. Date : 2024-09-10

    DMF Number : 40227

    Submission : 2024-08-30

    Status : Active

    Type : II

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    08

    Azelastine Hydrochloride

    U.S.A
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    Curia

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-01-27

    Pay. Date : 2014-01-16

    DMF Number : 19422

    Submission : 2006-05-05

    Status : Active

    Type : II

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    09

    Aztreonam Alfa Form

    U.S.A
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    Booth #S-3
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    Curia

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39731

    Submission : 2024-05-21

    Status : Active

    Type : II

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    10

    Aztreonam Alfa Form

    U.S.A
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    Curia

    GDUFA

    DMF Review : Complete

    Rev. Date : 2019-08-13

    Pay. Date : 2019-06-03

    DMF Number : 33762

    Submission : 2019-04-09

    Status : Active

    Type : II

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    Beclometasone dipropionate

    U.S.A
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    Curia

    Certificate Numbers : R1-CEP 2008-034 - Rev 01

    Status : Valid

    Issue Date : 2021-10-19

    Type : Chemical

    Substance Number : 654

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    02

    Betamethasone dipropionate

    U.S.A
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    Curia

    Certificate Numbers : R1-CEP 2002-031 - Rev 03

    Status : Valid

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 809

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    03

    Betamethasone sodium phosphate

    U.S.A
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    Curia

    Certificate Numbers : R1-CEP 2002-032 - Rev 01

    Status : Valid

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 810

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    04

    Betamethasone sodium phosphate, Process ...

    U.S.A
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    Curia

    Certificate Numbers : R0-CEP 2023-167 - Rev 00

    Status : Valid

    Issue Date : 2023-08-23

    Type : Chemical and TSE

    Substance Number : 810

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    05

    Betamethasone sodium phosphate, Process ...

    U.S.A
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    Curia

    Certificate Numbers : CEP 2025-201 - Rev 01

    Status : Valid

    Issue Date : 2026-03-10

    Type : Chemical

    Substance Number : 810

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    06

    Betamethasone valerate

    U.S.A
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    Curia

    Certificate Numbers : R1-CEP 2003-022 - Rev 02

    Status : Valid

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 811

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    07

    Bromocriptine mesilate

    U.S.A
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    Curia

    Certificate Numbers : R1-CEP 2000-151 - Rev 07

    Status : Valid

    Issue Date : 2021-08-05

    Type : Chemical

    Substance Number : 596

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    08

    Budesonide

    U.S.A
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    Curia

    Certificate Numbers : R1-CEP 2007-007 - Rev 02

    Status : Valid

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 1075

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    09

    Budesonide, Sterile

    U.S.A
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    Curia

    Certificate Numbers : R1-CEP 2009-037 - Rev 02

    Status : Valid

    Issue Date : 2021-08-24

    Type : Chemical

    Substance Number : 1075

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    10

    Chlortalidone, Milled; unmilled; microni...

    U.S.A
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    Curia

    Certificate Numbers : CEP 2001-020 - Rev 09

    Status : Valid

    Issue Date : 2024-03-07

    Type : Chemical

    Substance Number : 546

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    01

    Alclometasone dipropionate micronized Pr...

    U.S.A
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    Curia

    Registration Number : 308MF10024

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2026-02-06

    Latest Date of Registration : 2026-02-06

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    02

    Betamethasone Butyrate Propionicate micr...

    U.S.A
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    Curia

    Registration Number : 231MF10083

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2019-04-05

    Latest Date of Registration : 2019-04-05

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    03

    Betamethasone valerate

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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    Curia

    Registration Number : 222MF10158

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2010-05-24

    Latest Date of Registration : 2010-05-24

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    04

    Clobetasol propionate

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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    Curia

    Registration Number : 222MF10016

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2010-01-07

    Latest Date of Registration : 2010-01-07

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    05

    Cyclofenil

    U.S.A
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    Curia

    Registration Number : 221MF10049

    Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy

    Initial Date of Registration : 2009-03-09

    Latest Date of Registration : 2009-06-05

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    06

    Day stations betamethasone acid ester so...

    U.S.A
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    Curia

    Registration Number : 219MF10235

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2007-07-06

    Latest Date of Registration : 2007-07-06

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    07

    Day stations dexamethasone (production o...

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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    Curia

    Registration Number : 218MF10748

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2006-09-06

    Latest Date of Registration : 2010-03-17

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    08

    Day stations triamcinolone acetonide

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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    Curia

    Registration Number : 220MF10216

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2008-10-17

    Latest Date of Registration : 2008-10-17

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    09

    Day stations triamcinolone acetonide ste...

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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    Curia

    Registration Number : 221MF10001

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2009-01-13

    Latest Date of Registration : 2025-08-21

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    10

    Dexamethasone Propionate

    U.S.A
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    Curia

    Registration Number : 217MF11173

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2005-12-12

    Latest Date of Registration : 2009-12-15

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    Chlorthalidone

    U.S.A
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    Curia

    Registrant Name : Seongyi Bio Co., Ltd.

    Registration Date : 2019-11-26

    Registration Number : 20191126-209-J-283

    Manufacturer Name : Curia Italy SrL@Micro-Macinazi...

    Manufacturer Address : Viale Europa 5, I-21040 Origgio (VA), Italy@Zona Artigianale 11 6995-Madonna del pian...

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    02

    Clobetasolpropionate

    U.S.A
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    Curia

    Registrant Name : Goodwills Co., Ltd.

    Registration Date : 2008-05-30

    Registration Number : 20080530-93-E-56-03

    Manufacturer Name : Curia Spain SAU

    Manufacturer Address : Parque Tecnologico de Boecillo, Parcela 105, 47151- Boecillo (Valladolid)

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    03

    Clobetasolpropionate

    U.S.A
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    Curia

    Registrant Name : Donggoo Biopharmaceutical Co., Ltd.

    Registration Date : 2011-05-16

    Registration Number : 20080530-93-E-56-03(1)

    Manufacturer Name : Curia Spain SAU

    Manufacturer Address : Parque Tecnologico de Boecillo, Parcela 105, 47151- Boecillo (Valladolid)

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    Cyclosporine

    U.S.A
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    Curia

    Registrant Name : AbbVie Korea

    Registration Date : 2015-06-18

    Registration Number : 20150618-18-C-338-07

    Manufacturer Name : Curia Italy Srl

    Manufacturer Address : Via Volturno, 41/43 - 20089 ROZZANO (MI), Italy

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    05

    Deoxycholic acid

    U.S.A
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    Curia

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2020-07-07

    Registration Number : 20200707-210-J-659

    Manufacturer Name : Curia Spain SAU

    Manufacturer Address : Parque Tecnológico Boecillo, Parcela 105, Boecillo, 47151 Valladolid, Spain

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    Dexamethasone

    U.S.A
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    Curia

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2019-12-03

    Registration Number : 20191203-209-J-494

    Manufacturer Name : CURIA SPAIN SAU

    Manufacturer Address : Parque Tecnologico Parcela 105, Boecillo, 47151 Valladolid, Spain

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    07

    Dexamethasone

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2022-04-18

    Registration Number : 20191203-209-J-494(1)

    Manufacturer Name : Curia Spain SAU

    Manufacturer Address : Parque Tecnológico Boecillo, Parcela 105, Boecillo, 47151 Valladolid, Spain

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    08

    Dorzolamide hydrochloride

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2022-11-10

    Registration Number : 20211115-209-J-1151(D)

    Manufacturer Name : CURIA SPAIN SAU

    Manufacturer Address : Parque Tecnologico de Boecillo Parcela 105, Boecillo, 47151 Valladolid, Spain

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    09

    Dorzolamide hydrochloride

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Registrant Name : Clasia Co., Ltd.

    Registration Date : 2022-04-08

    Registration Number : 20211115-209-J-1151(C)

    Manufacturer Name : CURIA SPAIN SAU

    Manufacturer Address : Parque Tecnológico Boecillo, Parcela 105, Boecillo, 47151 Valladolid, Spain

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    10

    Dorzolamide hydrochloride

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Registrant Name : Samil Pharmaceutical Co., Ltd.

    Registration Date : 2023-01-06

    Registration Number : 20211115-209-J-1151(B)

    Manufacturer Name : CURIA SPAIN SAU

    Manufacturer Address : Parque Tecnológico de Boecillo, Parcela 105. 47151 Boecillo, Valladolid, Spain

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    NDC API

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    01

    ABIRATERONE ACETATE

    U.S.A
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    Booth #S-3
    • fda
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 65089-0051

    Start Marketing Date : 2011-04-28

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR HUMAN PR...

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    02

    ACECLIDINE HYDROCHLORIDE

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 55486-1608

    Start Marketing Date : 2024-09-19

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    03

    ALCAFTADINE

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 65089-0063

    Start Marketing Date : 2023-03-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    04

    ALCLOMETASONE DIPROPIONATE

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 65089-0012

    Start Marketing Date : 2005-07-18

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR HUMAN PR...

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    05

    ALTRENOGEST

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 65089-0048

    Start Marketing Date : 2014-11-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    ARGATROBAN

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 55486-1607

    Start Marketing Date : 2015-03-23

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    ARGATROBAN

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 55486-1582

    Start Marketing Date : 2012-06-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    ARTESUNATE

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 65089-0057

    Start Marketing Date : 2007-06-21

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR HUMAN PR...

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    09

    ATRACURIUM BESYLATE

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 55486-1597

    Start Marketing Date : 2012-06-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    10

    AZELASTINE HYDROCHLORIDE

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    NDC Package Code : 55486-1575

    Start Marketing Date : 2012-06-03

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    LISTED APIs

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Alclometasone Dipropionate

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    01

    Alclometasone Dipropionate

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Altrenogest

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    02

    Altrenogest

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Amphetamine

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    03

    Amphetamine

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Amphetamine Aspartate

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    04

    Amphetamine Aspartate

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Argatroban

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    05

    Argatroban

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Argatroban Monohydrate

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    06

    Argatroban Monohydrate

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Azelastine Hydrochloride

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    07

    Azelastine Hydrochloride

    U.S.A
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Aztreonam

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    08

    Aztreonam

    U.S.A
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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Bamifylline

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    Bamifylline

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    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    BECLOMETHASONE 17,21-DIPROPIONATE

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    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and...
    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    BECLOMETHASONE 17,21-DIPROPIONATE

    U.S.A
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    Curia

    Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deliver integrated solutions spanning small molecules, generic APIs, sterile drug products, and biologics. Our robust global network, advanced technologies, and flexible, scalable teams enable efficient development and reliable supply, accelerating the journey of high-quality therapies from concept to patients worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

    About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expertise, we deli...

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    Drugs in Development

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Curia Supports Replicate Bioscience's Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine

    Details:

    RBI-4000, is a self-replicating (srRNA) rabies vaccine, which is investigated in a Phase 1 clinical study utilizing clinical material developed as part of the collaboration with Curia.


    Lead Product(s): RBI-4000

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Vaccine

    Recipient: Replicate Bioscience

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 13, 2023

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    Curia

    U.S.A
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    Lead Product(s) : RBI-4000

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Recipient : Replicate Bioscience

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Curia Supports Replicate Bioscience's Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine

    Details : RBI-4000, is a self-replicating (srRNA) rabies vaccine, which is investigated in a Phase 1 clinical study utilizing clinical material developed as part of the collaboration with Curia.

    Product Name : Undisclosed

    Product Type : Vaccine

    Upfront Cash : Inapplicable

    September 13, 2023

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    Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Humanized anti-SARS-CoV-2 Monoclonal Antibodies from Curia Gl...

    Details:

    Murine monoclonal antibodies have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.


    Lead Product(s): Undisclosed

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Antibody, Unconjugated

    Sponsor: Tonix Pharmaceuticals Holding Corp

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement December 12, 2022

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    Curia

    U.S.A
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    Lead Product(s) : Undisclosed

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Tonix Pharmaceuticals Holding Corp

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Humaniz...

    Details : Murine monoclonal antibodies have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Undisclosed

    December 12, 2022

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    Incannex Engages Curia to Scale-up Manufacture of cGMP IHL-216A

    Details:

    IHL-216A (cannabidiol) has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD, and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration.


    Lead Product(s): Cannabidiol,Isoflurane

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Controlled Substance

    Recipient: Incannex Healthcare

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement August 02, 2022

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    Curia

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    Lead Product(s) : Cannabidiol,Isoflurane

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Preclinical

    Recipient : Incannex Healthcare

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Incannex Engages Curia to Scale-up Manufacture of cGMP IHL-216A

    Details : IHL-216A (cannabidiol) has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD, and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    August 02, 2022

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    First Patient Dosed in the ENLIGHTEN Biomarker-Guided Global Clinical Trial of DB104 (Liafensine) for Treatment-Resistant Depression

    Details:

    Denovo discovered a novel genetic biomarker for DB104 (liafensine) efficacy using its unique machine learning approach with whole genome sequencing to identify biomarkers that may be predictive of a patient's response to a specific medicine.


    Lead Product(s): Liafensine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Recipient: Denovo Biopharma

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 28, 2022

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    Curia

    U.S.A
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    Lead Product(s) : Liafensine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II

    Recipient : Denovo Biopharma

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    First Patient Dosed in the ENLIGHTEN Biomarker-Guided Global Clinical Trial of DB104 (Liafensine) ...

    Details : Denovo discovered a novel genetic biomarker for DB104 (liafensine) efficacy using its unique machine learning approach with whole genome sequencing to identify biomarkers that may be predictive of a patient's response to a specific medicine.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 28, 2022

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    Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development Platform for Self-Replicating RNA (srRNA)

    Details:

    As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials.


    Lead Product(s): Undisclosed

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Oligonucleotide

    Sponsor: Replicate Bioscience

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration June 09, 2022

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    Curia

    U.S.A
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    Lead Product(s) : Undisclosed

    Therapeutic Area : Immunology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Replicate Bioscience

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development ...

    Details : As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials.

    Product Name : Undisclosed

    Product Type : Oligonucleotide

    Upfront Cash : Undisclosed

    June 09, 2022

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    Curia Named Exclusive API Supplier for Recently Approved Acne Treatment

    Details:

    Curia has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.


    Lead Product(s): Clascoterone

    Therapeutic Area: Dermatology Brand Name: Winlevi

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Cassiopea

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement October 30, 2020

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    Curia

    U.S.A
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    Lead Product(s) : Clascoterone

    Therapeutic Area : Dermatology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Cassiopea

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Curia Named Exclusive API Supplier for Recently Approved Acne Treatment

    Details : Curia has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.

    Product Name : Winlevi

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    October 30, 2020

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    BryoLogyx Announces Completion of World’s First GMP Synthesis of Bryostatin-1

    Details:

    Bryostatin-1 is the company’s lead compound being developed to improve patient outcomes by amplifying the response and increasing the durability of targeted cancer immunotherapies.


    Lead Product(s): Bryostatin-1

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Miscellaneous

    Recipient: BryoLogyx Inc

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 13, 2020

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    Curia

    U.S.A
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    Lead Product(s) : Bryostatin-1

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Recipient : BryoLogyx Inc

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    BryoLogyx Announces Completion of World’s First GMP Synthesis of Bryostatin-1

    Details : Bryostatin-1 is the company’s lead compound being developed to improve patient outcomes by amplifying the response and increasing the durability of targeted cancer immunotherapies.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 13, 2020

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    Curia Selected to Support AstraZeneca in Delivery of COVID-19 Vaccine

    Details:

    Curia has been chosen to contribute to the supply of the vaccine candidate through sterile fill/finish of AZD1222 at Curia’s drug product manufacturing facility in Albuquerque, New Mexico.


    Lead Product(s): ChAdOx1 nCoV-19

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Vaccine

    Sponsor: AstraZeneca

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement September 03, 2020

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    Curia

    U.S.A
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    Lead Product(s) : ChAdOx1 nCoV-19

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : AstraZeneca

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Curia Selected to Support AstraZeneca in Delivery of COVID-19 Vaccine

    Details : Curia has been chosen to contribute to the supply of the vaccine candidate through sterile fill/finish of AZD1222 at Curia’s drug product manufacturing facility in Albuquerque, New Mexico.

    Product Name : Undisclosed

    Product Type : Vaccine

    Upfront Cash : Undisclosed

    September 03, 2020

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    Tryp Therapeutics Partners with Curia to Manufacture a Proprietary Psilocybin-based Drug

    Details:

    Curia will provide research, development and cGMP manufacturing of a proprietary psilocybin active pharmaceutical ingredient to support the clinical development of Psilocybin (TRP-8802), TRP-8803 and TRP-8804 programs.


    Lead Product(s): Psilocybine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Controlled Substance

    Sponsor: Tryp Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership August 13, 2020

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    Curia

    U.S.A
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    Lead Product(s) : Psilocybine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Tryp Therapeutics

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Tryp Therapeutics Partners with Curia to Manufacture a Proprietary Psilocybin-based Drug

    Details : Curia will provide research, development and cGMP manufacturing of a proprietary psilocybin active pharmaceutical ingredient to support the clinical development of Psilocybin (TRP-8802), TRP-8803 and TRP-8804 programs.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    August 13, 2020

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    ViralClear, Curia Enter COVID-19 Partnership

    Details:

    The companies together are undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators.


    Lead Product(s): Merimepodib,Remdesivir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Vicromax

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: BioSig Technologies

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership July 08, 2020

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    Curia

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    Lead Product(s) : Merimepodib,Remdesivir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : BioSig Technologies

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    ViralClear, Curia Enter COVID-19 Partnership

    Details : The companies together are undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators.

    Product Name : Vicromax

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    July 08, 2020

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    KEY PRODUCTS

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    API Manufacturing

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    Biologic Drugs

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    PEPTIDE DRUG PRODUCT MANUFACTURING

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    Pharma Service : Drug Product Manufacturing

    Curia

    Curia has the capability to offer sterile dosage forms containing proteins and peptides, suspensions, liposomes and nanoparticles, monoclonal antibodies, etc.

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    Category : Biologic Drugs

    Sub Category : Protein / Peptide

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    Pharma Service : Drug Product Manufacturing

    PEPTIDE DRUG PRODUCT MANUFACTURING

    Curia has the capability to offer sterile dosage forms containing proteins and peptides, suspensions, liposomes and nanoparticles, monoclonal antibodies, etc.

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    MONOCLONAL ANTIBODY DRUG PRODUCTS

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    Pharma Service : Drug Product Manufacturing

    Curia

    Curia has the capability to offer sterile drug products containing monoclonal antibodies, proteins and peptides, suspensions, liposomes and nanoparticles, etc.

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    Category : Biologic Drugs

    Sub Category : Monoclonal Antibody

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    Pharma Service : Drug Product Manufacturing

    MONOCLONAL ANTIBODY DRUG PRODUCTS

    Curia has the capability to offer sterile drug products containing monoclonal antibodies, proteins and peptides, suspensions, liposomes and nanoparticles, etc.

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    STERILE BIOLOGICAL PRODUCT MANUFACTURING

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    Pharma Service : Drug Product Manufacturing

    Curia

    Curia has the capability to offer sterile drug products containing biologics and small molecules, viscous biopolymers, suspensions, liposomes and nanoparticles, controlled drugs (schedule II-V), etc.

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    Category : Biologic Drugs

    Sub Category : Others

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    Pharma Service : Drug Product Manufacturing

    STERILE BIOLOGICAL PRODUCT MANUFACTURING

    Curia has the capability to offer sterile drug products containing biologics and small molecules, viscous biopolymers, suspensions, liposomes and nanoparticles, controlled drugs (schedule II-V), etc.

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    Sterile Biological Product Manufacturing

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    Injectable / Parenteral

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    01

    CLINICAL SUPPLY OF INJECTABLES

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    CDMO Live Europe 2026
    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : Drug Product Manufacturing

    Curia

    Curia leverages its expertise and capabilities to manufacture sterile drug products at any scale, from early clinical through large-scale commercial supply.

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    Category : Injectable / Parenteral

    Sub Category : Clinical Supply

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : Drug Product Manufacturing

    CLINICAL SUPPLY OF INJECTABLES

    Curia leverages its expertise and capabilities to manufacture sterile drug products at any scale, from early clinical through large-scale commercial supply.

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    Clinical Supply of Injectables

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    02

    MANUFACTURING OF STERILE DOSAGE FORMS

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : Drug Product Manufacturing

    Curia

    Curia offers services for the manufacture of sterile dosage forms, including sterile liquids, suspended or lyophilized biological or pharmaceutical products, aseptically filled or terminally sterilised, on a commercial-sized scale.

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    Category : Injectable / Parenteral

    Sub Category : Overview

    • fda
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    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : Drug Product Manufacturing

    MANUFACTURING OF STERILE DOSAGE FORMS

    Curia offers services for the manufacture of sterile dosage forms, including sterile liquids, suspended or lyophilized biological or pharmaceutical products, aseptically filled or terminally sterilised, on a commercial-sized scale.

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    Manufacturing of Sterile Dosage Forms

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    03

    CONTROLLED SUBSTANCE INJECTABLES

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    CDMO Live Europe 2026
    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : Drug Product Manufacturing

    Curia

    Curia offers sterile drug product manufacturing for controlled drugs (schedule I to V), monoclonal antibodies, antibody-drug conjugates and proteins or peptides.

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    Category : Injectable / Parenteral

    Sub Category : Controlled Substance

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : Drug Product Manufacturing

    CONTROLLED SUBSTANCE INJECTABLES

    Curia offers sterile drug product manufacturing for controlled drugs (schedule I to V), monoclonal antibodies, antibody-drug conjugates and proteins or peptides.

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    Controlled Substance Injectables

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    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    Preformulation & Material Science

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    01

    PREFORMULATION SERVICES

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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia has development capabilities for preformulation and formulation along with materials science and solid-state chemistry.

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    Category : Preformulation & Material Science

    Sub Category : Overview

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    PREFORMULATION SERVICES

    Curia has development capabilities for preformulation and formulation along with materials science and solid-state chemistry.

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    Preformulation Services

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    02

    SOLID STATE CHEMISTRY

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    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia offers drug substance development through its expertise in solid-state chemistry, materials science and engineering principles.

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    Category : Preformulation & Material Science

    Sub Category : Solid State Characterization

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    SOLID STATE CHEMISTRY

    Curia offers drug substance development through its expertise in solid-state chemistry, materials science and engineering principles.

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    Formulation Development

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    01

    DEVELOPMENT OF INJECTABLE DOSAGE FORMS

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    CDMO Live Europe 2026
    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia provides the development of pharmaceutical formulations for injectable dosage forms with a range of capabilities, including sterile liquid formulation, sterile freeze-dried formulation, sterile colloidal and viscous formulation, etc.

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    Category : Formulation Development

    Sub Category : Injectable / Parenteral

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    DEVELOPMENT OF INJECTABLE DOSAGE FORMS

    Curia provides the development of pharmaceutical formulations for injectable dosage forms with a range of capabilities, including sterile liquid formulation, sterile freeze-dried formulation, sterile colloidal and viscous formulation, etc.

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    Development of Injectable Dosage Forms

    Service
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    #ServicesBio

    Market
    Place

    02

    FORMULATION DEVELOPMENT SERVICES

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia provides formulation development for injectable, oral & topical dosage forms. Its capabilities include sterile liquid formulation, sterile freeze-dried formulation, sterile colloidal and viscous formulation, etc.

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    Category : Formulation Development

    Sub Category : Overview

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    FORMULATION DEVELOPMENT SERVICES

    Curia provides formulation development for injectable, oral & topical dosage forms. Its capabilities include sterile liquid formulation, sterile freeze-dried formulation, sterile colloidal and viscous formulation, etc.

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    Formulation Development Services

    Service
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    #ServicesBio

    Market
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    03

    STERILE LIQUID FORMULATION DEVELOPMENT

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    CDMO Live Europe 2026
    Booth #S-3
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    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia is a CDMO that develops liquid dosage forms. It has the capability to develop sterile liquid formulation, sterile freeze-dried formulation, sterile colloidal formulation, etc.

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    Category : Formulation Development

    Sub Category : Sterile Liquid Formulation

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    STERILE LIQUID FORMULATION DEVELOPMENT

    Curia is a CDMO that develops liquid dosage forms. It has the capability to develop sterile liquid formulation, sterile freeze-dried formulation, sterile colloidal formulation, etc.

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    Sterile Liquid Formulation Development

    Service
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    Capabilities
    #ServicesBio

    Market
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    API Development

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    01

    BIOCATALYSIS SERVICES

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    CDMO Live Europe 2026
    Booth #S-3
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    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia provides a complete suite of bioanalytical, biocatalysis and bioprocess services to address your drug discovery and development objectives.

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    Category : API Development

    Sub Category : Biocatalysis

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    BIOCATALYSIS SERVICES

    Curia provides a complete suite of bioanalytical, biocatalysis and bioprocess services to address your drug discovery and development objectives.

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    Biocatalysis Services

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    #ServicesBio

    Market
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    02

    DEVELOPMENT OF COMPLEX APIs

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
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    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia provides scientific expertise and state-of-the-art technologies to support the chemical development and cGMP manufacturing of complex APIs, including generics, potent and cytotoxic compounds, sterile APIs, steroids and controlled substances.

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    Category : API Development

    Sub Category : Complex APIs

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    DEVELOPMENT OF COMPLEX APIs

    Curia provides scientific expertise and state-of-the-art technologies to support the chemical development and cGMP manufacturing of complex APIs, including generics, potent and cytotoxic compounds, sterile APIs, steroids and controlled substances.

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    Development of Complex APIs

    Service
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    #ServicesBio

    Market
    Place

    03

    STEROID API DEVELOPMENT

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
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    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia offers drug development of steroids and hormones, supported by dedicated contract manufacturing facilities.

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    Category : API Development

    Sub Category : Steroid / Hormone

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    STEROID API DEVELOPMENT

    Curia offers drug development of steroids and hormones, supported by dedicated contract manufacturing facilities.

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    Steroid API Development

    Service
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    #ServicesBio

    Market
    Place

    04

    CRYSTALLIZATION PROCESS DEVELOPMENT

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
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    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia provides crystallization process development, early formulation design and development data, solid-state analysis and troubleshooting.

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    Category : API Development

    Sub Category : Crystallization Process

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    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    CRYSTALLIZATION PROCESS DEVELOPMENT

    Curia provides crystallization process development, early formulation design and development data, solid-state analysis and troubleshooting.

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    Crystallization Process Development

    Service
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    #ServicesBio

    Market
    Place

    05

    API CUSTOM SYNTHESIS

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
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    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia has a complete suite of synthetic and medicinal chemistry capabilities, including custom synthesis, route design, parallel synthesis and complex chemistries (eicosanoids, polysaccharides).

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    Category : API Development

    Sub Category : Custom Synthesis

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    API CUSTOM SYNTHESIS

    Curia has a complete suite of synthetic and medicinal chemistry capabilities, including custom synthesis, route design, parallel synthesis and complex chemistries (eicosanoids, polysaccharides).

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    API Custom Synthesis

    Service
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    #ServicesBio

    Market
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    06

    ROUTE DESIGN AND DEVELOPMENT

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
    • fda
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    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia has a complete suite of synthetic and medicinal chemistry capabilities, including route design, custom synthesis, parallel synthesis and complex chemistries (eicosanoids, polysaccharides).

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    Category : API Development

    Sub Category : Route Evaluation & Development

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    ROUTE DESIGN AND DEVELOPMENT

    Curia has a complete suite of synthetic and medicinal chemistry capabilities, including route design, custom synthesis, parallel synthesis and complex chemistries (eicosanoids, polysaccharides).

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    Route Design and Development

    Service
    Web Link

    Capabilities
    #ServicesBio

    Market
    Place

    07

    CDMO FOR HIGHLY POTENT APIs

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia offers development of high-potency APIs and DEA-licensed controlled substances. It has expertise in the cGMP production of highly potent compounds, from a few grams to hundreds of kilograms per year.

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    Category : API Development

    Sub Category : High Potency APIs (HPAPIs)

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    CDMO FOR HIGHLY POTENT APIs

    Curia offers development of high-potency APIs and DEA-licensed controlled substances. It has expertise in the cGMP production of highly potent compounds, from a few grams to hundreds of kilograms per year.

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    CDMO for Highly Potent APIs

    Service
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    Market
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    08

    CONTROLLED SUBSTANCE API DEVELOPMENT

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia is a manufacturer of controlled substances that develops scalable manufacturing processes. It offers controlled substance API development and manufacturing services and provides opioid APIs, and highly potent controlled substances.

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    Category : API Development

    Sub Category : Controlled Substance

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    CONTROLLED SUBSTANCE API DEVELOPMENT

    Curia is a manufacturer of controlled substances that develops scalable manufacturing processes. It offers controlled substance API development and manufacturing services and provides opioid APIs, and highly potent controlled substances.

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    Controlled Substance API Development

    Service
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    Market
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    09

    SMALL SCALE API PRODUCTION

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
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    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Coupled with the synthesis of intermediates and GMP raw materials, Curia offers cGMP manufacturing of APIs, from small scale to production scale.

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    Category : API Development

    Sub Category : Scale-Up Capabilities

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    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    SMALL SCALE API PRODUCTION

    Coupled with the synthesis of intermediates and GMP raw materials, Curia offers cGMP manufacturing of APIs, from small scale to production scale.

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    Small Scale API Production

    Service
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    #ServicesBio

    Market
    Place

    10

    CUSTOM API DEVELOPMENT

    U.S.A
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    CDMO Live Europe 2026
    Booth #S-3
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    Curia

    Curia is a global contract research, development and manufacturing organisation (CDMO) known for the discovery and development of the active pharmaceutical ingredients (APIs).

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    Category : API Development

    Sub Category : Overview

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCuria - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

    Pharma Service : API & Drug Product Development

    CUSTOM API DEVELOPMENT

    Curia is a global contract research, development and manufacturing organisation (CDMO) known for the discovery and development of the active pharmaceutical ingredients (APIs).

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    Inspections and registrations

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    Others

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    THIRD-PARTY AUDIT

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    Eurofins Assurance

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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Curia

    Country : Spain

    City/Region : Valladolid

    Audit Date : 2026-09-03

    Audit Type : On-Site

    Eurofins Assurance

    02

    Eurofins Assurance

    Belgium
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    CPhI Milan
    Exhibiting
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Curia

    Country : Spain

    City/Region : Valladolid

    Audit Date : 2025-12-04

    Audit Type : On-Site

    Eurofins Assurance

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    Eurofins Assurance

    Belgium
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    CPhI Milan
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Curia

    Country : India

    City/Region : Aurangabad

    Audit Date : 2025-08-21

    Audit Type : On-Site

    Eurofins Assurance

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    Eurofins Assurance

    Belgium
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    CPhI Milan
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Curia

    Country : Spain

    City/Region : Valladolid

    Audit Date : 2025-06-12

    Audit Type : On-Site

    Eurofins Assurance

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    Eurofins Assurance

    Belgium
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    CPhI Milan
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Curia Italy

    Country : Italy

    City/Region : Rozzano

    Audit Date : 2025-04-16

    Audit Type : On-Site

    Eurofins Assurance

    06

    Eurofins Assurance

    Belgium
    arrow
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    CPhI Milan
    Exhibiting
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    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Curia Italy

    Country : Italy

    City/Region : Origgio

    Audit Date : 2024-01-25

    Audit Type : On-Site

    Eurofins Assurance
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    ABOUT THIS PAGE

    Contact Curia and get a quotation

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