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    TAPI and Sagimet Biosciences Announce Global License Agreement

    19 Dec 2025

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    Antheia links with TAPI to scale biosynthetic drug ingredients

    21 Nov 2025

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    TAPI Builds Greener Future With Sustainable API Manufacturing

    29 Sep 2025

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    TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. 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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    INTERVIEW #SpeakPharma

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    “We were able to secure our crucial supplies throughout the pandemic”

    mic“We were able to secure our crucial supplies throughout the pandemic”

    The ongoing Covid-19 pandemic has been challenging for supply chain management professionals at pharmaceutical companies across the world, especially during the lockdowns where they were under tremendous pressure to produce critical drugs and often even step up production. With borders closed and restrictions on movement, active pharmaceutical ingredient (API) manufacturers such as Teva api had to work with governments and freight operators, and work with new guidelines and strategies, to overcome the supply chain challenges. This week, we interview Bertil Wagensveld, Head of Logistics & Commercial Supply Chain at Teva api, to understand how he managed to ensure a crucial supply of APIs to Europe from his base in Amsterdam. — How has the pandemic impacted pharmaceutical and API manufacturers? Can you talk about some of the supply chain challenges you faced during the lockdowns? The pandemic has been extremely challenging for all businesses and professionals. It has been particularly challenging in a critical industry like pharmaceuticals and API, where we have to move essential medicines and ingredients around the world. For instance, when we had to shut down our site in China temporarily at the start of the outbreak in 2020, we realized what a problem it was for our global supply. In Europe, specifically in Italy where most of our products are produced, it became an emergency. Our customers began contacting us almost immediately to understand the potential impact on their supply, specifically asking us whether we had sufficient raw material, about the origin of the raw material, and if we had sufficient inventory. In parallel, we also contacted our raw material suppliers and our service providers to understand the potential impact of this emergency. It was a challenge; it still is a challenge — one where we are learning each day. It makes me incredibly proud that we were able to secure our crucial supplies and reduce the impact of this unexpected situation. — Since medicines are essential commodities, how did governments work with companies like yours to ensure supplies? We have a few medicines which were, and still are, in high demand in hospitals. Right from the start, we were approached by governments to understand the potential availability and delivery dates for these products. With border congestions all over Europe at the start of the pandemic, there was a lot of confusion. Thankfully, the European Union understood that guidelines were required to ensure that the supply of essential goods would continue despite border congestion. Together with our government affairs department and our forwarders, we implemented the European guidelines for the transportation of APIs. What about delivery? How did you manage to get the products across closed borders? It was not an easy operation. Initially, we were extremely dependent on our forwarders’ day-to-day updates about the situation in each country and at the borders. When the European Union established their guidelines, we implemented them quickly to ensure business continuity.  For land transportation, the biggest challenge was border congestion, which we monitored on a daily and sometimes even on an hourly basis, together with our service providers to avoid any significant delays or hold-ups. Occasionally, we had to change to a longer route to avoid border congestion. For airfreight, the biggest challenge has been the significant drop in the availability of cargo space. We had already established close contacts with cargo freighters around the world, and we worked closely with our strategic logistics service providers to access available space on flights, ensure pre-booking, and closely monitor the freight rates. For sea bookings, we did experience a shortage of sea containers. Fortunately, we overcame this problem, and it didn’t have a significant impact on our supply.  — How did Teva api employees cope with the challenges? Like everyone in the world, our employees also coped with challenges on both the personal and professional fronts, such as homeschooling their children and looking after elderly family members, while continuing to work. We are very proud of the team for their commitment and their adaptability. Our virtual connectivity helped us set the right priorities for the team and share a platform for personal experiences.  — How did Teva api manage production during the height of the pandemic? Physical presence during production could have exposed your employees to the virus. This was, of course, one of our biggest concerns. Safety of our employees is always our utmost priority. Our Environment, Health, and Safety (EHS) and Human Resource (HR) departments established Covid safety rules in all our production sites around the world to ensure the safety of our employees at all times. We were very impressed by the commitment of our employees, and we barely experienced any impact on our operations. I also believe that all our employees understood the importance of their jobs during this time and the impact it has had on our family, friends, and society. We were able to continue production without any significant disruption.  

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    15 Nov 2021
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2026

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    Revolutionary Dry Ice Shipping for APIs Below -70°C

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    Revolutionizing API Production with AI and Machine Learning

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    GMP Certificate 2024

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    DATA COMPILATION #PharmaFlow

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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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    13 Nov 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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    NEWS #PharmaBuzz

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    TAPI and Sagimet Biosciences Announce Global License Agreement
    TAPI and Sagimet Biosciences Announce Global License Agreement

    19 Dec 2025

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    https://tapi.com/knowledge-center/tapi-and-sagimet-biosciences-announce-global-license-agreement-for-innovative-forms-of-resmetirom-api-for-sagimets-fixed-dose-combination-program/

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    19 Dec 2025
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    Antheia links with TAPI to scale biosynthetic drug ingredients
    Antheia links with TAPI to scale biosynthetic drug ingredients

    21 Nov 2025

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    https://tapi.com/knowledge-center/tapi-and-antheia-announce-strategic-partnership-to-advance-commercialization-of-biosynthetic-pharmaceutical-ingredients/

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    21 Nov 2025
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    TAPI Builds Greener Future With Sustainable API Manufacturing
    TAPI Builds Greener Future With Sustainable API Manufacturing

    29 Sep 2025

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    https://tapi.com/knowledge-center/sustainable-by-design-how-tapi-is-building-a-greener-future-in-api-manufacturing/

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    29 Sep 2025
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    Automation And AI Reshape Solid Form Development In Pharma
    Automation And AI Reshape Solid Form Development In Pharma

    25 Aug 2025

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    https://tapi.com/knowledge-center/how-innovative-computational-tools-and-automation-are-reshaping-solid-form-development/

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    25 Aug 2025
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    Redox Biocatalysis Enables Green Chemistry With Stereocontrol
    Redox Biocatalysis Enables Green Chemistry With Stereocontrol

    28 Jul 2025

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    https://tapi.com/knowledge-center/driving-innovation-in-green-chemistry-redox-biocatalysis-allowing-full-stereocontrol/

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    28 Jul 2025
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    TAPI Boosts Fermentation Efficiency With Smart Automation
    TAPI Boosts Fermentation Efficiency With Smart Automation

    21 Jul 2025

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    https://tapi.com/knowledge-center/driving-bioprocess-innovation-how-tapi-is-transforming-fermentation-efficiency-with-smart-automation/

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    21 Jul 2025
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