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    Nieké van Gils, Jr. scientist at Aspen API on international women’s day.

    07 Mar 2024

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    Gold Medal for Aspen API in EcoVadis Evaluation

    31 Oct 2023

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    Fine Chemicals Corporation facility in Cape Town, South Africa was inspected by the PMDA.

    31 Oct 2023

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    Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen API works tirelessly to deliver top-quality APIs to clients worldwide. Aspen API has a portfolio of over 58 high-quality APIs, including high potency, oncology, peptides, narcotics, analgesics, botanical extractions, and biochemicals. Aspen API places a strong emphasis on sustainability. It employs eco-friendly technologies and solvents in its chemical processes, ensuring responsible and environmentally conscious manufacturing.

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    Product List 2024

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    Peptide Development and Manufacturing Capabilities

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    DATA COMPILATION #PharmaFlow

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

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

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

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

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ir