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    USFDA Concludes cGMP Audit at Cohance’ API Manufacturing Plant

    11 Sep 2025

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    Cohance Lifesciences Q1 FY26 Revenue Grows by 13%

    13 Aug 2025

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    Cohance to Spend $10M on cGMP Bioconjugation Suite in NJ Bio

    12 Aug 2025

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    Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expertise in complex chemistries, we provide end-to-end CDMO solutions to global innovators. As a global API player, we serve customers in nearly 60 countries with 80+ molecules, supported by robust R&D, regulatory capabilities, and advanced manufacturing infrastructure, including strong backward-integrated pellet manufacturing. 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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    VLOG #PharmaReel

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    ReelPharmaLeading CDMO & API PlatformLeading CDMO & API Platform

    Leading CDMO & API Platform
    Leading CDMO & API Platform

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    Your premier partner for end-to-end CDMO and API solutions, Cohance delivers excellence from concept and lab to global supply.

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2026

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    GMP Certificate 2024

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    FDF Product List 2026

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    API Product List 2026

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    Intermediate Product List 2026

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    Pellet Product List 2026

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    Antibody-Drug Conjugate Brochure 2024

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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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    Impressions: 1005

    https://www.pharmacompass.com/radio-compass-blog/cep-q1-2026-update-cep-2-0-edqm-s-new-guidelines-strengthen-ecosystem-indian-firms-top-list-of-ceps-issued

    #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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    Impressions: 4024

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

    #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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    Impressions: 3823

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-veranova-chemexpress-invest-in-adc-facilities-cohance-to-set-up-oligonucleotide-facility-in-india

    #PharmaFlow by PHARMACOMPASS
    16 Oct 2025
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    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired  Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord).  Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation. 
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    10 Jul 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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    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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    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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    USFDA Concludes cGMP Audit at Cohance’ API Manufacturing Plant
    USFDA Concludes cGMP Audit at Cohance’ API Manufacturing Plant

    11 Sep 2025

    // BSE INDIA

    https://www.bseindia.com/xml-data/corpfiling/AttachHis/ca5aa02f-13a0-4706-9442-5243e6ac4d09.pdf

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    11 Sep 2025
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    Cohance Lifesciences Q1 FY26 Revenue Grows by 13%
    Cohance Lifesciences Q1 FY26 Revenue Grows by 13%

    13 Aug 2025

    // BSE INDIA

    https://www.bseindia.com/xml-data/corpfiling/AttachHis/a5bb5a8f-229c-40b8-b3cb-c40f09a91bdb.pdf

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    13 Aug 2025
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    Cohance to Spend $10M on cGMP Bioconjugation Suite in NJ Bio
    Cohance to Spend $10M on cGMP Bioconjugation Suite in NJ Bio

    12 Aug 2025

    // PRESS RELEASE

    https://www.cohance.com/wp-content/uploads/2025/08/Cohance-Lifesciences-Press-Release_Bioconjugation.pdf

    PRESS RELEASE
    12 Aug 2025
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    Cohance Invests 23 Cr in Hyderabad cGMP Oligonucleotide Facility
    Cohance Invests 23 Cr in Hyderabad cGMP Oligonucleotide Facility

    12 Aug 2025

    // BSE INDIA

    https://www.bseindia.com/xml-data/corpfiling/AttachHis/4342a713-49ac-4ad7-b534-d6b8c4faa670.pdf

    BSE INDIA
    12 Aug 2025
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    Cohance Lifesciences Names Yann D'Herve as CDMO Business CEO
    Cohance Lifesciences Names Yann D'Herve as CDMO Business CEO

    29 Jul 2025

    // PRESS RELEASE

    https://www.cohance.com/wp-content/uploads/2025/07/PR-Cohance-Lifesciences-names-Yann-DHerve-as-CEO.pdf

    PRESS RELEASE
    29 Jul 2025
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    Cohance Appoints Yann D'Herve as CEO of CDMO Business
    Cohance Appoints Yann D'Herve as CEO of CDMO Business

    28 Jul 2025

    // PRESS RELEASE

    https://www.cohance.com/wp-content/uploads/2025/07/PR-Cohance-Lifesciences-names-Yann-DHerve-as-CEO.pdf

    PRESS RELEASE
    28 Jul 2025
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    01

    Rivaroxaban

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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    Issue Date : 2024-06-28

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    Substance Number : 2932

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    Registrant's Address : 215 Atrium, C Wing, 8th Floor, 819-821, Andheri Kurla Road, Chakala MIDC, Chakala, Andheri East, Mumbai-400 093 Maharash

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    Start Marketing Date : 2017-06-05

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    Manufacturer Address : Plot No. 3102/B GIDC, Industrial Estate Ankleshwar-393 002, Dist. Bharuch, Gujarat state, India

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    Aripiprazole

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    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-11-16

    Pay. Date : 2017-10-18

    DMF Number : 30120

    Submission : 2015-12-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-021 - Rev 02

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 2617

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-18

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76072-1002

    Start Marketing Date : 2016-04-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2018-03-16

    Registration Number : 20180316-209-J-68

    Manufacturer Name : Cohance Lifesciences Limited

    Manufacturer Address : API Unit-Ⅲ, Plot No. 3102/B GIDC, Industrial Estate Ankleshwar-393 002, Dist. Bharuch, Gujarat state, India

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

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    Market
    Place

    03

    Atomoxetine

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-27

    Pay. Date : 2019-12-03

    DMF Number : 29211

    Submission : 2015-03-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-150 - Rev 01

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-18

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76072-1011

    Start Marketing Date : 2017-06-05

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF CA, CN, ... arrow-down
    ✖
    Available Reg. Filing : CA, CN, RU
    AUDIT
    Cohance

    Product
    Web Link

    Stock Recap
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    Market
    Place

    04

    Dipyridamole

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-18

    Pay. Date : 2015-09-29

    DMF Number : 29745

    Submission : 2015-09-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-148 - Rev 02

    Issue Date : 2026-02-03

    Type : Chemical

    Substance Number : 1199

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-24

    Valid Till : 2028-07-21

    Written Confirmation Number : WC-0150N

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-122

    Start Marketing Date : 2020-01-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF CA, RU arrow-down
    ✖
    Available Reg. Filing : CA, RU
    AUDIT
    Cohance

    Product
    Web Link

    Stock Recap
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    Market
    Place

    05

    Doxazosin Mesylate

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-31

    Pay. Date : 2019-12-23

    DMF Number : 22941

    Submission : 2009-07-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-312 - Rev 03

    Issue Date : 2023-10-27

    Type : Chemical

    Substance Number : 2125

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-24

    Valid Till : 2028-07-21

    Written Confirmation Number : WC-0150N

    Address of the Firm :

    NDC KDMF VMF ASMF, CA... arrow-down
    ✖
    Available Reg. Filing : ASMF, CA, RU
    AUDIT
    Cohance

    Product
    Web Link

    Stock Recap
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    Market
    Place

    06

    Entacapone

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-24

    Pay. Date : 2015-09-29

    DMF Number : 23937

    Submission : 2010-06-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-006 - Rev 02

    Issue Date : 2026-02-26

    Type : Chemical

    Substance Number : 2574

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-24

    Valid Till : 2028-07-21

    Written Confirmation Number : WC-0150N

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-109

    Start Marketing Date : 2010-07-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2019-03-20

    Registration Number : 20190320-209-J-208

    Manufacturer Name : Cohance Lifesciences Limited

    Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, NTR District-521 457, Andhra Pradesh, India

     VMF CN, CA, ... arrow-down
    ✖
    Available Reg. Filing : CN, CA, RU
    AUDIT
    Cohance

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Fluvoxamine

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-01-04

    Pay. Date : 2017-10-18

    DMF Number : 29582

    Submission : 2015-07-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-089 - Rev 04

    Issue Date : 2024-09-27

    Type : Chemical

    Substance Number : 1977

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-18

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76072-1003

    Start Marketing Date : 2016-04-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Lamotrigine

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-29

    Pay. Date : 2013-03-20

    DMF Number : 23251

    Submission : 2009-11-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-417 - Rev 00

    Issue Date : 2022-12-15

    Type : Chemical

    Substance Number : 1756

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-24

    Valid Till : 2028-07-21

    Written Confirmation Number : WC-0150N

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-103

    Start Marketing Date : 2022-02-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2022-12-12

    Registration Number : 20220112-209-J-1158(A)

    Manufacturer Name : Cohance Lifescience Limited

    Manufacturer Address : API Unit-I, RS 50/1, Mukteswarapuram Village, Jaggaiahpet Mandal, NTR District – 521 457, Andhra Pradesh, India

     VMF CA, CN, ... arrow-down
    ✖
    Available Reg. Filing : CA, CN, RU, BR
    AUDIT
    Cohance

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Midazolam

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-03

    Pay. Date : 2015-02-12

    DMF Number : 26871

    Submission : 2013-02-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-141 - Rev 03

    Issue Date : 2025-12-09

    Type : Chemical

    Substance Number : 936

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-24

    Valid Till : 2028-07-21

    Written Confirmation Number : WC-0150N

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-115

    Start Marketing Date : 2020-01-17

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2021-03-25

    Registration Number : 20210325-210-J-815

    Manufacturer Name : Cohance Lifesciences Limited

    Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, NTR District-521 457, Andhra Pradesh, India

     VMF ASMF, CA... arrow-down
    ✖
    Available Reg. Filing : ASMF, CA, RU, BR
    AUDIT
    Cohance

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Tamsulosin

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-23

    Pay. Date : 2015-08-27

    DMF Number : 28648

    Submission : 2014-09-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-014 - Rev 06

    Issue Date : 2026-02-23

    Type : Chemical

    Substance Number : 2131

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-07-24

    Valid Till : 2028-07-21

    Written Confirmation Number : WC-0150N

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-118

    Start Marketing Date : 2020-01-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF CA, CN, ... arrow-down
    ✖
    Available Reg. Filing : CA, CN, RU, BR
    AUDIT
    Cohance

    Product
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    Cohance Lifesciences

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    Contact Cohance Lifesciences and get a quotation

    Cohance Lifesciences is a supplier offers 90 products (APIs, Excipients or Intermediates).

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