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    Aarti Pharmalabs Schedules Board Meet For Q Results

    28 Jan 2026

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    Aarti Pharmalabs Appoints Dr. Rakeshwar Bandichhor as CSO

    04 Jan 2026

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    Aarti Pharmalabs Launches Ph 1 of Greenfield Manufacturing Site

    03 Sep 2025

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    Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

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    Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, etc.). It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 3 R&D centers and 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.

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    Product List 2024

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    Intermediates Product List 2023

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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: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

    CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

    The contract development and manufacturing organization (CDMO) sector has emerged as a key partner in new drug development. This was evident from the strategic investments, partnerships, and expansions witnessed in the third quarter (Q3) of 2025. Several CDMOs, such as Cohance Lifesciences, Fermion Oy, Axplora, AGC Pharma Chemicals invested in new projects. Others, including Veranova, Aenova, and Biosynth, expanded capacities, while Ofichem strengthened its footprint with the acquisition of Avivia BV. CDMOs like Fareva, Evonik, and Samsung Biologics forged strategic partnerships for growth. During Q3, the sector continued to adopt artificial intelligence (AI). This prompted the US Food and Drug Administration (FDA) to issue guidance that recognizes the increasing use of AI and data analytics in drug development.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Cohance, Veranova invest in bioconjugation suites in US; ChemExpress inks ADC deal Earlier this year, Indian drugmaker Suven Pharmaceuticals Limited merged with  leading CDMO Cohance Lifesciences Limited. The merged entity — Cohance Lifesciences — has invested US$ 10 million in a current Good Manufacturing Practice (cGMP) bioconjugation suite at its subsidiary NJ Bio in Princeton, New Jersey.  NJ Bio is executing a major program for an existing innovator client with multiple antibody-drug conjugate (ADC) candidates. Cohance also announced an INR 230 million (approximately US$ 2.58 million) investment in a cGMP oligonucleotide facility at its Hyderabad (India) site. Veranova’s Devens (Massachusetts) site successfully passed a routine FDA cGMP surveillance inspection with a “No Action Indicated” (NAI) classification. Earlier, the company had initiated a US$ 50 million investment to expand its ADC and bioconjugate capabilities at its Devens site. This includes a 9,000-square-foot facility expansion with a new process development lab, two additional cGMP suites, and state-of-the-art bioconjugation development and manufacturing capabilities. These initiatives strengthen the site’s highly potent API (HPAPI) and ADC development and manufacturing capabilities. Biosynth has expanded its Berlin facility with a new GMP bioconjugation suite. The expansion supports the company’s manufacturing capabilities in conjugate vaccines, conjugate drugs, activated polyethylene glycol (PEGs), and polymer-based drug delivery excipients. ChemExpress, Mabwell Bioscience, and Insilico Medicine have entered into a strategic partnership to jointly develop a large ADC compound library and advance next-generation ADC candidates. The collaboration combines Mabwell’s antibody and ADC technology, Insilico’s AI-powered drug design platform, and ChemExpress’s expertise in linker-payload chemistry. Together, they aim to build a complete, AI-driven ADC development model that accelerates discovery, optimization, and commercialization. This partnership is expected to enhance R&D efficiency and deliver safer, more effective cancer treatments.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Fermion, Axplora, Aenova increase API manufacturing capacities; ICE Pharma expands India facility Finnish CDMO Fermion Oy has launched a renovation project at its Hanko (Finland) production site to modernize its API manufacturing capabilities. This expansion is part of Fermion's broader strategy to increase production, enhance flexibility in the manufacturing of both existing and future pharmaceutical products, and enable potential contract manufacturing opportunities. German CDMO Axplora has announced a €6.5 million (approximately US$ 7.5 million) investment to expand its API manufacturing capacity at its Vizag site in India. This expansion aims to strengthen both production capabilities and supply chain resilience. India-based Aarti Pharmalabs has inaugurated the first phase of its greenfield manufacturing facility in Gujarat (India). This expansion aims to bolster Aarti's CDMO and contract manufacturing organization (CMO) services, targeting a revenue goal of INR 10 billion (approximately US$ 112 million). Snapdragon Chemistry, which was acquired by Cambrex in 2023, has expanded its Massachusetts facility to better support peptide drug development and manufacturing. With this upgrade, the company can now handle peptide projects from early development through full-scale manufacturing. Italy-headquartered ICE Pharma has expanded its Raichem facility in India. The new facility will enhance the production of ursodeoxycholic acid (UDCA), an API it derives from chicken bile. This expansion increases the site’s raw UDCA output by 120 metric tons annually. Spain-headquartered AGC Pharma Chemicals inaugurated a new advanced manufacturing plant in Barcelona, with an investment of €110 million (approximately US$ 128.3 million). The plant spans 7,500 square meters and integrates cutting-edge technologies to support the entire drug development lifecycle — from R&D to commercial manufacturing. This represents a 30 percent increase in the company’s production capacity and introduces a segment dedicated to HPAPIs. Germany-headquartered Aenova has launched a new hot melt extrusion platform at its Regensburg (Germany) site. This new equipment enables the production of advanced drug formulations, while handling all testing and quality checks in-house. The move strengthens Aenova’s capabilities in developing and manufacturing complex medications. US-based Cytovance Biologics has introduced in-house formulation development services, enhancing its role as a comprehensive partner for biologic drug developers. These services utilize quality-by-design principles to ensure speed, safety, and precision in current and future client programs.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Ofichem acquires Avivia BV; Evonik, Samsung Biologics form strategic collaborations Europe-based CDMO Ofichem Group announced the acquisition of Avivia BV, a formulation development company in the Netherlands. This acquisition is part of Ofichem’s strategy to become a fully integrated provider of development solutions across both drug substance and drug product, with a focus on complex formulations. Ofichem has also acquired Meribel Pharma Solutions’ site in Uppsala (Sweden) to strengthen its support for biotech innovators and expand its presence in the Nordic region.  Simtra BioPharma Solutions has acquired a 65-acre property near its Bloomington, Indiana (US) facility, adding over 300,000 square feet of potential expansion space. With this site, Simtra now has the flexibility to rapidly expand in the US. German specialty chemicals company Evonik is partnering with German biotech Ethris to develop and commercialize a next-generation lipid nanoparticle (LNP) platform for delivering nucleic acid therapies. Evonik will assist in formulation using Ethris’ SNaP LNP technology. The LNP market alone is projected to grow to US$2.3 billion by 2032. Luxembourg-headquartered Fareva has partnered with Zhaoke Ophthalmology to expand its footprint in China’s pharma market. Zhaoke will act as Fareva’s go-to partner for customers seeking pharmaceutical manufacturing in China. Samsung Biologics has signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based drugmaker. And UK-based eXmoor Pharma has partnered with Anthony Nolan to provide end-to-end services for cell therapy developers.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Our view The global CDMO market, valued at around US$ 255 billion in 2025, is projected to grow to over US$ 465 billion by 2032. Significantly, about 60 percent of new drug approvals in the US and over 65 percent in Europe now involve CDMO support. The developments outlined above underscore the increasing role CDMOs are playing today in bringing about growth and innovation in the pharmaceutical industry.  
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    #PharmaFlow by PHARMACOMPASS
    16 Oct 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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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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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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    Aarti Pharmalabs Schedules Board Meet For Q Results
    Aarti Pharmalabs Schedules Board Meet For Q Results

    28 Jan 2026

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    Aarti Pharmalabs Appoints Dr. Rakeshwar Bandichhor as CSO
    Aarti Pharmalabs Appoints Dr. Rakeshwar Bandichhor as CSO

    04 Jan 2026

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    Aarti Pharmalabs Launches Ph 1 of Greenfield Manufacturing Site
    Aarti Pharmalabs Launches Ph 1 of Greenfield Manufacturing Site

    03 Sep 2025

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    Aarti Pharmalabs Annual Report 2024-25
    Aarti Pharmalabs Annual Report 2024-25

    28 Aug 2025

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    Aarti Pharmalabs's Credit Rating Upgraded to CRISIL AA-/Stable
    Aarti Pharmalabs's Credit Rating Upgraded to CRISIL AA-/Stable

    29 Jul 2025

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    Aarti Pharmalabs Earns EcoVadis Gold for Sustainability
    Aarti Pharmalabs Earns EcoVadis Gold for Sustainability

    29 Apr 2025

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