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    PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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    PMC Isochem, acquired by PMC International in 2017, is a CDMO manufacturing cGMP intermediates, APIs, and functional excipients for global pharmaceutical and personal care companies. It offers research, development, pilot and industrial production, and regulatory support, with US FDA-audited facilities within 60 miles of Paris. PMC Isochem drives innovation and adds value to clients' intellectual property throughout the product lifecycle. 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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    Global Portfolio: dmo@pmcisochem.fr

     

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    ReelPharmaSmart & Innovative Custom ManufacturingSmart & Innovative Custom Manufacturing

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    Smart & Innovative Custom Manufacturing

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    This PharmaReel highlights PMC Isochem, a smart custom manufacturing partner that offers Generic APIs, cGMP Intermediates, Vitamin E TPGS, and cutting-edge drug delivery materials, supported by trusted CDMO & CRO services and certified by the USFDA and EDQM.

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    Isodel® Vitamin E TPGS

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    Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

    Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

    The market for pharmaceutical excipients — or inactive substances used in the production of drugs —  continued to witness significant transformation in the first quarter (Q1) of 2026. The rise of biologics, increasing demand for personalized medicine, and innovations in drug delivery systems are driving demand for a wider range of functional excipients. As a result, the pharmaceutical excipients market is estimated to grow at a compound annual growth rate (CAGR) of 5.75 percent, to exceed US$ 15.43 billion by 2034. Its size was estimated at US$ 9.31 billion in 2025. The North American market for excipients was estimated at US$ 3.1 billion in 2024 and is estimated to increase to US$ 5.66 billion by 2034. In comparison, the European market for pharmaceutical excipients was estimated at US$ 2.35 billion in 2024 and is predicted to reach around US$ 3.95 billion by 2034, while the Asia Pacific market stood at US$ 1.94 billion in 2024 and is projected to grow to US$ 3.65 billion by 2034.The sector remains highly competitive and fragmented. Major excipient providers include BASF, Roquette, Gangwal Healthcare, Croda International, DuPont, Seqens, SPI Pharma, Evonik, PMC Isochem, Pfanstiehl, Colorcon, Kewpie Corporation, ICE Pharma, Nanjing Well Pharmaceutical, Merck KGaA-owned MilliporeSigma, Minakem, Ashland Global and Nippon Fine Chemical.Clariant sets up its first PEG excipients facility in US; Croda opens greenfield facility in India Swiss specialty chemical company Clariant is expanding its Clear Lake (Texas) site to include GMP-compliant manufacturing of pharmaceutical-grade polyethylene glycol (PEG) excipients. This will improve availability and reliability for North American customers, with extended reach to Latin America. The multi-phase expansion addresses critical industry priorities around supply chain security, continuity, and responsiveness while demonstrating Clariant’s long-term strategic commitment to the US pharmaceutical market. This is the first Clariant facility in the US to manufacture PEG excipients for oral and topical applications.British specialty chemicals company Croda International has inaugurated a greenfield manufacturing facility in Dahej, India, that strengthens its ability to serve fast-growing markets in Asia. The new site represents a significant investment in India and will enhance Croda’s supply capabilities, improve responsiveness to customer demand, and support future growth in high-value sectors. Located in Gujarat, the facility benefits from strong logistics connectivity and is designed to serve both domestic customers and select export markets. It will support demand across Croda’s consumer care, life sciences, and industrial specialties sectors. Following the acquisition of IFF Pharma Solutions in 2025, French excipient company Roquette has introduced an expanded cosmetics portfolio under the Roquette Beauté brand. This portfolio integrates IFF Pharma Solutions’ ingredients — Methocel, Avicel, Aquacoat, Ethocel, and Polyox — with Roquette’s legacy range, while its core portfolio continues to include widely used pharmaceutical excipients. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)SPI Pharma-Anek Prayog, Ingredion-Univar ink distribution deals; DFE Pharma, Gericke launch CM platformIn February, US-based pharmaceutical excipient and ingredients company SPI Pharma announced a global distribution partnership with Indian pharmaceutical excipient manufacturer Anek Prayog. Under this agreement, SPI will exclusively sell, promote, and distribute Lubripharm Pro SSF, a next-generation sodium stearyl fumarate lubricant manufactured by Anek Prayog.The Ingredients + Specialties division of Univar Solutions was appointed as a distributor for Ingredion Pharma Solutions. The agreement includes distribution of Ingredion’s global pharmaceuticals portfolio and positions Univar as the exclusive distributor of pharmaceutical starches in the US and Canada. The partnership expands its pharmaceutical and nutraceutical excipient offerings, including binders, fillers, superdisintegrants, lubricants, and gelatin alternatives.German excipient solutions company DFE Pharma has launched a continuous manufacturing (CM) platform in collaboration with Switzerland-based Gericke Group to support formulation development, optimization, and lifecycle management. The platform integrates CM-ready excipients, a flexible evaluation environment, and multidisciplinary expertise to enable data-driven decisions from early development to commercial manufacturing.As part of this initiative, DFE Pharma has established CM capabilities at its C2F Center of Excellence in Hyderabad, featuring a Gericke Formulation Skid (GFS) in a non-GMP setup. This modular system enables rapid testing, process optimization, and practical assessment of continuous feeding and blending without impacting existing GMP operations, while supporting alignment with ICH Q13 (an international guideline on CM for drug substances and products).Gangwal Healthcare operates EXCiPACT-certified GMP facilities and offers a broad range of functional excipients, including co-processed blends like ProBlend, Starlose, Tyloxapole, and Microlose. Its excipients, including Solvostar (sodium starch glycolate) and LubMag-W (Magnesium Stearate, Sodium Lauryl Sulfate), support enhanced tablet disintegration and drug release. The company also provides taste-masking agents such as SucreX (sucralose) and CutCal (neotame), supporting the development of patient-friendly oral dosage forms. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)India harmonizes 22 excipient monographs; EMA updates TE guidelines for inhalation products Regulators are increasingly tightening requirements around excipients, as they are no longer treated as passive ingredients. They are being recognized as critical to product performance and therapeutic equivalence.India has introduced the Indian Pharmacopoeia 2026 with updated and harmonized standards for pharmaceutical ingredients, including 22 excipient monographs. These revisions align Indian standards more closely with global pharmacopoeias. For excipient manufacturers and drug formulators, this means stricter compliance expectations. In August, India had notified an amendment to the Drugs Rules, 1945 to mandate inclusion of qualitative details of excipients in drug labels through barcodes or QR codes from 2026.The European Medicines Agency (EMA) has issued updated guidelines on the pharmaceutical quality of inhalation and nasal medicines, as well as on demonstrating therapeutic equivalence (TE) of orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease. These guidelines require manufacturers to provide detailed information on the active substance, finished product composition, pharmaceutical development studies, and the control of excipients and other formulation components. Similar pharmaceutical quality requirements apply to nasal products under the pharmaceutical quality guideline.Excipients are becoming increasingly linked to manufacturing technologies. For instance, the US Food and Drug Administration (FDA) finalized its Advanced Manufacturing Technologies (AMT) Designation Program in 2024. This is expected to increase the need for excipients compatible with such technologies. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)Our view While the market for excipients is growing at a healthy pace, the ongoing conflict in the Middle East is disrupting pharmaceutical supply chains, with impacts now extending beyond APIs to critical excipients and packaging materials. Surging crude oil prices are driving up the cost of excipients, with key inputs like chloroform witnessing sharp price increases. In addition, disruptions in logistics are forcing drugmakers to reroute shipments through longer and more expensive routes due to closure of airports and certain sea routes. These developments will have a cascading effect on the pharmaceutical industry and its supply chain in the coming months.
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    26 Mar 2026
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    Excipient Market Overview: Evonik launches high-purity excipients; India mandates disclosures from March 2026

    Excipient Market Overview: Evonik launches high-purity excipients; India mandates disclosures from March 2026

    The global pharmaceutical excipients market continued to evolve in the third quarter (Q3) of 2025, supported by rising demand for functional excipients, growth in production of generics, and advances in drug delivery technologies. The global market for pharmaceutical excipients was estimated at US$ 9.8 billion to US$ 10.7 billion in 2024, and is projected to grow at a compound annual growth rate (CAGR) of 4.1 to 6.6 percent through 2030. At this pace, the market is expected to reach US$ 13.05 billion to US$ 14.86 billion by 2030. Europe retained the largest market share in 2024, followed by Asia-Pacific. Key drivers shaping the excipients market include the rising prevalence of chronic diseases, expansion of biologics and biosimilars, and increasing quality and regulatory expectations. Increased investments in facility expansions and ongoing reforms in clinical trial regulations are also facilitating market growth. The sector remains highly competitive and fragmented. Major excipient providers include BASF, Roquette, Gangwal Healthcare, DuPont, Evonik, Seqens, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Colorcon, Kewpie Corporation, ICE Pharma, Nanjing Well Pharmaceutical, Merck KGaA owned MilliporeSigma, Minakem, Ashland Global, Actylis and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)  Evonik in partnership with Ethris; Colorcon Ventures invests in Phytolon   The market saw strategic collaborations across the excipients and drug formulation ecosystem in Q3 2025. Evonik entered into a partnership with Ethris to strengthen its nucleic acid delivery platform. The collaboration integrates Ethris’ proprietary technology — its lipidoid nanoparticle platform, known as SNaP LNP — into Evonik’s CDMO offerings, enhancing the latter’s ability to support RNA-based therapeutics from concept to clinic. Colorcon Ventures, the investment arm of Colorcon, announced a strategic investment in Israel-based Phytolon. The biotechnology start-up uses precision fermentation to develop natural colorants. The investment underscores Colorcon’s commitment to next-generation coloring technologies that support cleaner-label formulations and innovation in oral solid dosage coatings.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Evonik launches MaxiPure Polysorbate 80; Asahi Kasei expands its portfolio The quarter saw continued innovation in high-purity and injectable-grade excipients. Evonik introduced MaxiPure Polysorbate 80, a high-purity injectable-grade surfactant designed for biologics and parenteral formulations. This excipient addresses key challenges such as protein stability, viral inactivation, and the solubilization of hydrophobic APIs, while meeting regulatory expectations across global markets. Asahi Kasei expanded its Sonanos portfolio of excipients with two new products — Sonanos PG (optimized for sustained release of biologics and peptides while supporting patient-friendly dosing)  and Sonanos DS (developed to enhance solubility of poorly water-soluble APIs). These additions reflect growing industry demand for dosage optimization, stability, and specialized delivery of complex molecules. Gangwal Healthcare operates EXCiPACT-certified GMP facilities and offers a broad range of functional excipients, including co-processed blends like ProBlend, Starlose, and Microlose. Its excipients, including Solvostar (sodium starch glycolate) and Sallyso (croscarmellose sodium), support enhanced tablet disintegration and drug release. The company also provides taste-masking agents such as SucreX (sucralose) and CutCal (neotame), supporting the development of patient-friendly oral dosage forms.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Colorcon, Gattefossé, Croda, Roquette, Clariant expand manufacturing capacities Manufacturing investments and facility expansions remained a key trend during Q3 2025. Colorcon inaugurated a new state-of-the-art, film coating manufacturing facility in Johor, Malaysia. The site incorporates energy-efficient systems and advanced production technologies to strengthen Colorcon’s functional-excipient supply network across Asia. Gattefossé opened a new lipid-based excipient facility in Texas (US), marking a strategic expansion of its North American manufacturing footprint. Croda International expanded its Leek, UK facility with a lipid system synthesis unit and enhanced R&D capabilities. The site will support the launch of Super Refined Poloxamer 188, a highly purified fast-dissolving granular excipient. Roquette announced the opening of a dedicated innovation center in São Paulo, Brazil, strengthening its engagement with regional drug developers. Clariant expanded its Daya Bay, China facility, adding a second spray tower dedicated to pharmaceutical excipient production. The upgraded site increases capacity for excipients used in laxatives and other formulations. BASF also strengthened its commitment to biopharma and pharmaceutical ingredients with a new GMP Solution Center in Michigan (US). The facility expands BASF’s network of poloxamer (a synthetic polymer) manufacturing sites. With state-of-the-art clean room packaging and high-sensitivity analytical testing, this new facility will enable close collaboration with BASF’s customers on customized chemistries for product development.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   India mandates excipient disclosure; new rules to apply from March 2026  India has made it mandatory to disclose excipient details from March 2026 under the country’s new Drugs (2nd Amendment) Rules, 2025. This applies to Schedule H2 medicines. The final notification expands earlier draft requirements by mandating qualitative excipient details in QR codes on product packaging. This should enhance transparency and support patient safety. Meanwhile, US pharmaceutical groups have responded to the US Food and Drug Administration’s draft guidance proposing simplified pathways for replacing color additives in drug products. Industry associations have supported draft guidance, noting that it reduces regulatory burden while maintaining product quality and consistency.  View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)   Our view While the fast-growing generics market is creating demand for cost-effective and versatile excipients, the market is also witnessing innovations tailored to the specialized needs of biologics and biosimilars. India is poised to become a key player in the global excipient market, supported by the rapid growth in its generic drug industry, expansion of its health infrastructure and increasing investments in R&D. The new excipient-disclosure rules, therefore, are likely to benefit the global excipient industry by improving transparency and strengthening quality ecosystems.
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    20 Nov 2025
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    Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

    Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

    The pharmaceutical excipients market saw significant strategic consolidations, technological developments, and regulatory adaptations in 2025. Globally, the pharmaceutical excipients sector is growing at a compound annual growth rate of 6.6 percent, and was valued at US$ 8.85 billion in 2024. It is projected to reach US$ 14.77 billion by 2032.This year, the sector is witnessing technological advancements, regulatory evolution, and strategic business realignments. North America continues to dominate the global excipients landscape, with a 39.8 percent market share. The Asia-Pacific region is the fastest-growing segment with a substantial 30.4 percent market share, driven by increasing investments in pharmaceutical manufacturing, growing demand for cost-effective drugs, and rising healthcare expenditure across developing economies.Major excipient providers include BASF, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, DuPont, Evonik, Seqens, Actylis, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Kewpie Corporation, Boai NKY Pharmaceuticals, ICE Pharma, Roquette, Nanjing Well Pharmaceutical, Minakem, Ashland Global, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Roquette restructures after buying IFF Pharma; Colorcon partners ASHA CelluloseIn May, Roquette completed its acquisition of IFF Pharma Solutions. Valued at up to US$ 2.85 billion in enterprise value, this transaction represents a major consolidation in the pharmaceutical excipients market. The acquisition significantly enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide. Roquette announced a comprehensive, new organizational structure following the acquisition, indicating the company’s commitment to integrate IFF Pharma Solutions’ capabilities seamlessly into its existing operations. This consolidation creates a more robust platform for addressing the growing demand for specialized excipients in complex drug formulations, particularly as the industry moves towards more personalized approaches to medicines.So far, the year has also witnessed some strategic alliances, such as Colorcon’s partnership with ASHA Cellulose. As part of the deal, Colorcon will become the exclusive representative for two ASHA products — ASHACEL and ASHAKOTE — throughout Europe, the Middle East, Africa, Northeast Asia and Southeast Asia.Brenntag Specialties has announced an exclusive distribution agreement with MEGGLE Excipients to expand market reach. This collaboration makes available a broad portfolio of over 30 high-quality lactose-based excipients for various applications in the pharmaceutical industries across the Netherlands, Belgium, Norway, Finland, and Sweden.The portfolio’s versatility offers optimal solutions for a wide range of pharmaceutical applications, including tableting through both granulation and direct compression, powder preparations, and dry powder inhalation. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)WHO, FDA drive new standards with GMP guidelines; Pfanstiehl launches injectable-grade glycineIn March, the World Health Organization had put out a publication titled “Good Manufacturing Practices for Excipients used in Pharmaceutical Products.” WHO’s excipient GMP guideline emphasizes modern quality management principles, comprehensive risk assessment protocols, and supplier qualification procedures for excipients across all stages of production, storage, and distribution.Meanwhile, the US Food and Drug Administration (FDA) has proposed amendments to the Food, Drug, and Cosmetic Act as part of its FY 2025 legislative proposals, specifically targeting supply chain transparency for high-risk excipients. The FDA proposal would require certain excipients designated as high-risk to carry labeling that identifies the original manufacturer’s name and address. This initiative addresses what FDA has identified as a lack of transparency in excipient supply chains.In April, IFF Pharma Solutions launched Low Nitrite METHOCEL hydroxypropyl methylcellulose (HPMC). This innovative product is specifically designed to reduce the risk of nitrosamine formation in finished pharmaceutical dosages, addressing one of the most pressing concerns in contemporary pharmaceutical manufacturing.Pfanstiehl, a global leader in high-purity excipient manufacturing, announced the launch of its High Purity Low Endotoxin Low Metals (HPLE-LM) injectable-grade glycine. This multi-compendial glycine is specifically engineered for use in biologics, vaccines, and the downstream purification of monoclonal antibodies (mAbs). Manufactured under ICH-Q7 cGMP regulations at Pfanstiehl’s advanced facility in Waukegan, Illinois, the product meets stringent global pharmacopeial standards. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Shin-Etsu Chemical invests in Japan, Germany to expand cellulose productionIn March, Shin-Etsu Chemical announced investments in pharmaceutical cellulose business operations in Japan and Europe, thereby showing significant commitment to market expansion. The company is making substantial investments at two key bases: the subsidiary SE Tylose GmbH in Germany, and the Naoetsu Plant in Joetsu, Japan. In Germany, a new production facility for the pharmaceutical excipient L-HPC will be built adjacent to the existing facility, creating a dual base with the Naoetsu Plant. The excipients market in 2025 has seen innovation in functional applications. Research on BENEO’s Palatinose as a bedtime drink shows that it improves aspects of sleep and represents an innovative approach to excipient functionality. Palatinose is a naturally sourced, smart carbohydrate that provides full carbohydrate energy in a more balanced way, thanks to its low-glycemic profile.Gangwal Healthcare, with its EXCiPACT-certified GMP facilities and a robust portfolio of co-processed excipients like ProBlend, Starlose, and Microlose, is actively contributing to the pharmaceutical industry’s demand for functional excipients. The company also offers cellulose-based excipients such as Solvostar (Sodium Starch Glycolate) and Sallyso (Croscarmellose Sodium), designed to improve tablet disintegration and drug release profiles in oral solid dosage forms.Evonik announced a partnership with South Korea–based CDMO ST Pharm to expand its RNA and nucleic acid delivery services. This collaboration enables Evonik to integrate customized nucleic acids from ST Pharm seamlessly with its lipid and lipid nanoparticle (LNP) development and fill-and-finish services. This streamlined approach means that pharmaceutical companies can reduce complexity and increase speed-to-market for nucleic acid therapeutics. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Our viewThe pharmaceutical excipients market in 2025 is being shaped by several key trends including the development of multifunctional excipients that can simultaneously improve solubility, bioavailability, and control drug release in increasingly complex formulations.Moreover, the expanding generic medicines market is creating demand for cost-effective, versatile excipients. The growing importance of biologics and biosimilars is driving innovation in specialized excipients designed to maintain the stability and efficacy of these complex therapeutic products throughout their lifecycle. And nanotechnology continues to enable advanced nano-excipients for enhanced drug delivery and efficacy.In addition to these trends, we also notice a shift towards natural and plant-based excipients that is driven by sustainability concerns and potential biocompatibility benefits. 
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    29 May 2025
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

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

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

    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   
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    Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.
    Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.
    Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.What are polyamino acids and PAA-based drug delivery systems?A polyamino acid, sometimes also called a p...
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    December, 2022
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    Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.

    Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.

    Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.What are polyamino acids and PAA-based drug delivery systems?A polyamino acid, sometimes also called a polypeptide, is a synthetic biopolymer made from amino acid monomeric units. Polyamino acids (PAAs) are comparable to proteins (and peptides) as they are also composed of amino acid building blocks linked by means of amide bonds.Structural and functional proteins, polypeptides, peptides and polymers derived from amino acids are called polyamino acids. Polyamino acids have several biological applications in tissue engineering, regenerative medicines and drug delivery systems, etc.Additionally, polyamino acids are endowed with remarkable biological functionalities, such as a target-specific delivery and rapid metabolization of their degraded products. The hydrophilicity of the amino acids influence the degradation rates of polyamino acids.The most important polyamide homo- and copolymers that are widely used in drug delivery are poly(amidoamine), polylysine, polyaspartic acid and poly(glutamic acid).Novel polymer-based drug delivery systems are being developed to change the physicochemical and pharmacokinetic characteristics of drug molecules for controlled delivery. The capability to enable unique and highly-targeted biological functions make proteins and peptides ideal candidates for drug delivery systems. The advantages of using Polyamino acids or polyamide polymer as a drug delivery system include localized target-specific delivery, biocompatibility, biodegradability, flexible physicochemical modification, slow degradability, sustained release and stabilization.Polyamino acids are widely utilized in the formulation of chemotherapeutics to achieve selective drug delivery for the right amount of time, which will reduce drug-related adverse effects and boost anti-tumor efficacy.What are the applications of polyamino acids based delivery?Poly(amino acid)s are the most commonly used polyamides in drug delivery. The use of peptides as carriers of nucleic acids for controlled delivery into target cells and organelles is one significant application of such functional materials. There are various other applications of polyamino acids which are as follows:- Poly(amino acid)s are utilized in a variety of medical and biological applications including cell adhesion, drug delivery, gene therapy, diagnostic, oncology, antibacterial, antifungal and surface chemistry.- Polyamino acids-based delivery systems have highly attractive material properties such as biodegradability, non-cytotoxicity, and mechanically durability. Natural polyamino acid (PAA) has been widely utilized in the controlled delivery of drug, protein and gene because of its excellent biocompatibility.- Polyamino acid based delivery is frequently utilized in targeted drug delivery and controlled drug delivery. Polyamino acids deliver a therapeutic to a targeted area through site-specific interactions, exploit transmembrane transport systems and deliver a therapeutic payload to a targeted site, devoid of side effects.- Water-soluble drug-polymer conjugates offer benefits such as enhanced drug pharmacokinetics and pharmacodynamics, minimal toxicity to essential organs, non-immunogenicity, tissues or cells and improved drug buildup at the target site to enhance targeted drug delivery via carrier-based systems.- Poly(amino acid)s are the first class of biomaterials and have biomedical applications because of which they are used as nonviral gene delivery vectors. Therefore, the design and synthesis of polyamino acid vectors are of great interest.- Microscale carrier is an important component of the drug delivery system that enables it to be well designed for enhancing the pharmacological and therapeutic features of drug administration.- Poly(amino acid)/polypeptide as functional materials have a variety of features like stimuli-responsive, self-assembling, nano-scale and self-healing- Silk is a structural protein that exhibits properties of self-assembly, mechanical toughness, processing flexibility, biodegradability & biocompatibility, making it extremely useful for several human therapeutic interventions.What are the different methods of synthesis of polyamino acids?In the field of sustainable chemistry and materials engineering, there is a growing interest in the development of an engineered biopolymer, such as a biomass-derived polyamide. Materials made of polyamino acids (PAAs) have attracted a lot of attention in the field of biomedicine because of their exceptional biocompatibility and biodegradability.Current synthesis techniques that are used to synthesize a biopolymer like a polypeptide and polyamino acid, such as solid-phase peptide synthesis and recombinant DNA techniques, still have problems with their production capacity, atom economy and sequence regulation. It is important to closely regulate the molecular weight within a narrow range when synthesizing polyamino acids (PAAs) for drug delivery and biomedical applications.Polypeptides are derived from the ring-opening polymerization of alpha-amino acid N-carboxyanhydrides (NCAs). Chemo-enzymatic synthesis can be used for the synthesis of polyamino acids. It is one possible option for the efficient synthesis of poly(amino acid)s, regarding yield, reaction time and atom economy.The production of polypeptides using the ring opening polymerization of amino acid N-Carboxyahydride monomers results in limited polydispersity, little side product formation, high reproducibility, flexible architectures and precise functionalization of the polypeptide backbone.Polymers based on amino acid monomers have attracted a lot of attention in drug delivery. As the manufacturing of PAA or polyamides involves numerous challenges, many companies prefer to outsource their needs. There are several  CDMOs for polyamino acids offering custom synthesis and manufacturing for GMP Polymers and copolymers based on various polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc.What are the polyamino acid based polymer manufacturing services offered by PMC Isochem?A contract development and manufacturing organization (CDMO), PMC Isochem provides amino acid based polymer diversity for drug delivery and innovative treatments. From R&D to GMP large-scale production, PMC Isochem offers polypeptide excipients and drug-polymer conjugates along with GMP polymers and copolymers based on various polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc.Polyamino acid based delivery is a major area of interest for advanced biomedicines because of its biocompatibility and biodegradability. The chemical & architectural versatility of polyamino acids & polypeptides is enormous. Polyamide acids are utilized in several therapeutic areas, including immunotherapy, oncology, gene therapy, inflammatory, neurodegenerative, infectious, diagnosis, skin care, etc. Synthetic GMP polyamino acids are being used in biomedical and drug delivery applications as they are structurally similar to naturally occurring proteins. Drug–polymer conjugates offer improved pharmacokinetic and properties with enhanced stability for targeted drug delivery.PMC Isochem is a CDMO for polyamino acids integrated in strategic monomers NCA (α-aminoacid N-CarboxyAnhydride) offeringStandard and customized GMP polyamino acidDevelopment and characterizationScale-up and clinical supplyCommercial manufacturingPMC Isochem has 40 years experience in large-scale GMP custom manufacturing  of polyamino acids (PAA) from kilolab to full-scale production. It has 3 production sites in France and has manufacturing facilities audited by the US & EU regulatory agencies.PMC Isochem is a widely known CDMO for polyamino acids. It provides custom-made Polyamino acid (PAA) design for its clients, which is supported by integrated NCA supply and development for GMP polymers and copolymers based on different polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc.PMC Isochem has a highly skilled and diversified R&D team with academic affiliations. It has fully equipped infrastructures and a network for accessing cutting-edge technologies for polyamino acid based delivery. PMC Isochem has a lean approach to provide cheaper, faster and better solutions, which allows its clients to save cost, time and risk. To help its customers grow their businesses, PMC Isochem has a flexible and creative business development team with IP portfolio and proprietary GMP polyamino acid (PAA) systems.

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    NEWS #PharmaBuzz

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    Welcome to the exciting world of innovation
    Welcome to the exciting world of innovation

    19 Jan 2026

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    https://pmcisochem.fr/article/welcome-exciting-world-innovation

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    19 Jan 2026
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    New services offered by PMC Isochem
    New services offered by PMC Isochem

    06 May 2024

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    06 May 2024
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    Welcome to the exciting world of innovation!
    Welcome to the exciting world of innovation!

    01 Dec 2023

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    https://pmcisochem.fr/article/welcome-exciting-world-innovation

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    01 Dec 2023
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    PMC Isochem – Your partner for Smart & Innovative Solutions
    PMC Isochem – Your partner for Smart & Innovative Solutions

    07 Sep 2022

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    https://www.pharmaexcipients.com/news/pmc-isochem-solutions/

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    07 Sep 2022
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    PMC Group Announces Acquisition of Copperhead Chemical
    PMC Group Announces Acquisition of Copperhead Chemical

    22 Feb 2021

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    https://pmcisochem.fr/article/pmc-group-international-announces-acquisition-copperhead-chemical-company

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    22 Feb 2021
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    PMC Isochem to accelerate Polyamino acids business as Part of ISO
    PMC Isochem to accelerate Polyamino acids business as Part of ISO

    16 Dec 2020

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    https://pmcisochem.fr/article/pmc-isochem-accelerate-polyamino-acids-business-part-isodel%C2%AE-drug-delivery-offer-unique-one

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    16 Dec 2020
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