Vadodara drug maker, dating to 1907, with three API plants and six formulation plants. Holds US DMFs for 6 peptide APIs, including glatiramer and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
77 listed companies hold active US Type II Drug Master Files (DMFs) for finished peptide APIs, covering 45 molecules. The data comes from FDA's public DMF list; intermediates, side chains and fragments are excluded.
A DMF lets a drug maker reference the API supplier's manufacturing information in its own FDA application. FDA does not approve DMFs, so a DMF is evidence of a regulatory filing, not of approval.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Vadodara drug maker, dating to 1907, with three API plants and six formulation plants. Holds US DMFs for 6 peptide APIs, including glatiramer and tirzepatide.
RK Pharma subsidiary offering API process R&D, custom synthesis and generic APIs, with US offices and plants in Gujarat and Andhra Pradesh. Holds US DMFs for 6 peptide APIs.
Aspen Pharmacare's API site in Oss, Netherlands, with roots in 1923; makes peptides with a liquid-phase process plus hormones and heparin. Holds US DMFs for 4 peptide APIs.
Tianjin unit of Asymchem, a CDMO listed in Shenzhen and Hong Kong that makes peptides and oligos; US DMFs for liraglutide and semaglutide.
Peptide API subsidiary of Aurobindo Pharma with a plant near Hyderabad. Makes generic peptide APIs and runs GMP contract projects from mg to kg scale.
Privately owned Barcelona peptide CDMO founded in 1989, making GMP generic peptide APIs and custom NCE peptides. Holds US DMFs for 10 peptide APIs.
Bengaluru biopharma company that makes generic APIs and complex formulations, including GLP-1 peptides. Holds US DMFs for liraglutide, semaglutide and tirzepatide.
Changzhou API and tablet maker founded 1949 with a record of US FDA, EU GMP and PMDA inspections; US DMFs for semaglutide and tirzepatide.
Hangzhou peptide CRDMO founded in 2001, part of CPC Scientific/Medtide, with production in China and the USA. Holds US DMFs for cetrorelix, semaglutide and tirzepatide.
Taiwanese API maker founded in 1964, trading as Cenra API Solutions, offering CMO/CDMO services. Holds US DMFs for difelikefalin, plecanatide and setmelanotide.
Mumbai drugmaker founded in 1936 with six plants, including a US-FDA-accredited API site at Roha; holds an active US DMF for semaglutide.
Hyderabad injectables CDMO founded 1978, promoted by Fosun Pharma; FDA-inspected sites; US DMF for glatiramer acetate.
Gwangju peptide API maker founded in 2000 as Anygen, KOSDAQ-listed since 2016, with MFDS-approved GMP peptide plants; holds US DMFs for ganirelix and vasopressin.
Riga drug maker operating since 1946 that now offers CDMO services; WHO-inspected oxytocin API site; US DMF for oxytocin.
Hyderabad-based MSN Group entity holding US DMFs for 11 peptide APIs, including semaglutide and tirzepatide. MSN runs 27 plants in India, the USA and Indonesia.
Indian CDMO whose Turbhe, Navi Mumbai site develops and makes peptide APIs by solid- and solution-phase synthesis. Holds US DMFs for 9 peptide APIs.
Hamburg microbial biologics CDMO founded 1987, now wholly owned by Gedeon Richter; FDA-inspected 2013, 2018 and 2026; US DMF for teriparatide.
Raichur API and CDMO subsidiary of Shilpa Medicare; US DMFs for desmopressin, liraglutide and octreotide; Raichur units inspected by US FDA in 2025.
Neijiang, Sichuan injectables and API maker founded in 2010, listed on Shanghai's STAR Market, with FDA and UK MHRA GMP inspections; holds an active US DMF for lanreotide.
Jiangsu peptide CDMO and generic API supplier with large automated SPPS capacity; states it has passed four US FDA inspections. Holds US DMFs for 9 peptide APIs.
Dutch holding entity of TAPI, Teva's API and CDMO business, with peptide development and GMP production across a global plant network. Holds US DMFs for 9 peptide APIs.
Chinese maker of generic small-molecule, peptide and oligonucleotide APIs, founded in 1998, with an FDA-inspected site in Yangzhou. Holds US DMFs for semaglutide and tirzepatide.
US peptide API CDMO with facilities in the US and China.
Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.
Greek peptide manufacturer producing GMP and non-GMP peptides and resins.
Chinese peptide drug manufacturer producing APIs and finished products.
Indian API manufacturer and CDMO with a peptide synthesis platform.
Peptide-focused CDMO running GMP manufacturing sites on three continents.
API manufacturer and CDMO focused on complex generics, including peptides.
Beijing API company, founded 2006, that holds DMFs and has its APIs made in partner facilities under its own quality control. Holds US DMFs for 13 peptide APIs.
US generics, specialty and biosimilars company with operations in the US, India and Ireland; US DMF for glatiramer acetate.
Nanjing API subsidiary of Nasdaq-listed Amphastar; US DMF for teriparatide.
Hyderabad API developer and maker founded in 2007, focused on niche and complex products. Holds US DMFs for cetrorelix, icatibant and sincalide.
California peptide synthesizer maker founded 1993 that also runs a cGMP peptide CDMO site in Milpitas; US DMF for triptorelin.
Italian API maker in the Italfarmaco Group, founded 1973, producing peptides since 1996; US DMFs for leuprolide and octreotide.
Chongqing maker of diabetes and obesity drugs, active since 2015 and controlled by Zhifei (300122) since 2025; US DMFs for liraglutide and semaglutide.
Chongqing API maker founded in 2016 covering high-potency APIs, peptides and XDC compounds with CDMO services; reports FDA on-site inspections in 2024 and 2025 and holds a US DMF for semaglutide.
European CDMO network with a dedicated peptide, lipid and carbohydrate platform.
Fresenius Kabi's Italian API unit; its Villadose site near Venice develops and makes peptide APIs, also offered through Fresenius Kabi contract manufacturing. Holds US DMFs for 6 peptide APIs.
Hangzhou recombinant drug maker listed in Hong Kong (02566), formerly Huadong Medicine's gene engineering centre; US DMF for liraglutide.
Hangzhou drug maker incorporated 1993, part of Shenzhen-listed Huadong Medicine; two group entities hold US DMFs for semaglutide.
Mumbai peptide API maker acquired by Piramal Pharma in 2021; its oxytocin API is WHO-prequalified; US DMF for oxytocin.
Main operating subsidiary of Hong Kong-listed Hansoh Pharma, founded 1995; holds US DMFs for degarelix and icatibant.
Shenzhen peptide CDMO and API maker founded in 2009, with 13 cGMP lines and 85,000 L of SPPS/LPPS reactor volume. Holds US DMFs for 6 peptide APIs.
Shenzhen-listed drug maker (002294) selling APIs and finished products; US DMF for bivalirudin.
Suzhou API and intermediate maker founded in 2000 offering CDMO/CMO services; holds an active US DMF for semaglutide.
Suzhou peptide API and formulation maker founded in 2000, flagship of Tianma Pharma Group, offering CRO/CMO/CDMO services. Holds US DMFs for 8 peptide APIs.
Dubai-incorporated subsidiary of Zydus Lifesciences, the Ahmedabad drug group listed in India; US DMF for semaglutide.
Beijing biotech founded in 2018 that develops and produces recombinant protein and peptide drugs in E. coli for metabolic disease; holds an active US DMF for semaglutide.
Swiss Debiopharm plant in Martigny making triptorelin sustained-release products; US DMF for triptorelin pamoate microgranules.
Shanghai bulk peptide maker supplying wholesalers; holds US DMFs for bremelanotide, semaglutide and tirzepatide.
Putian, Fujian peptide API maker founded in 2019 by New Hope and Taiwan's Genovior, focused on GLP-1 APIs. Holds US DMFs for semaglutide and tirzepatide.
Zunyi, Guizhou peptide manufacturer offering development and kg-scale production; holds active US DMFs for tirzepatide and other peptides.
Hangzhou peptide and oligonucleotide CRDMO supporting projects from preclinical to commercial supply; holds active US DMFs for tirzepatide and inclisiran.
Hangzhou peptide maker founded in 2014 offering pharmaceutical, cosmetic and catalog peptides plus peptide CRO/CDMO work; holds an active US DMF for semaglutide.
Hangzhou peptide developer offering peptide APIs, intermediates, impurities and ADC/PDC linkers plus custom synthesis and process development; holds an active US DMF for tirzepatide.
Hangzhou peptide API maker and CDMO founded in 2019, supplying therapeutic and cosmetic peptides. Holds US DMFs for linaclotide, semaglutide and tirzepatide.
Privately held Hyderabad generics and API group with 36+ plants; US DMFs for semaglutide and vasopressin.
Changchun biopharmaceutical maker of somatropin, semaglutide and other APIs; holds active US DMFs for semaglutide and somatropin.
Nanjing supplier of insulin and metabolic peptide APIs with technology transfer services; US DMFs for semaglutide and tirzepatide.
Ningxia API and peptide maker founded in 2016 in Pingluo, offering peptide API development and manufacturing; holds US DMFs for semaglutide and tirzepatide.
Weihai Sino-US joint venture founded 2016 making peptide APIs and cosmetic peptides; US DMFs for leuprolide and semaglutide.
Navi Mumbai biopharma and specialty pharma company; US DMFs for lanreotide and liraglutide.
Shenzhen peptide company founded in 2020 making GLP-1 peptide APIs, sterile vials and peptide reference materials at a Zhongshan plant; holds an active US DMF for tirzepatide.
Shenzhen synthetic-biology ingredient maker with semaglutide as its lead biopharma product; US DMFs for semaglutide main chain and side chain.
Leshan-based peptide producer founded in 2015 with SPPS and LPPS lines; holds US DMFs for eptifibatide, semaglutide and tirzepatide.
Suzhou peptide CRDMO with GMP workshops built to ICH Q7; US DMFs for semaglutide and tirzepatide.
Suzhou API and intermediates producer offering customized manufacturing. Holds US DMFs for semaglutide, thymalfasin and tirzepatide.
Wuhan fermentation-based CDMO founded 2008 making GLP-1 APIs, proteases and cell products; US DMFs for semaglutide and its main chain.
Nantong company founded in 2020 that makes peptides by biosynthesis and offers peptide CMC development. Holds US DMFs for semaglutide and tirzepatide.
Hangzhou company founded in 2020 that makes GLP-1 peptides by fermentation plus semi-synthesis; holds an active US DMF for semaglutide API.
Mumbai drug maker incorporated in 1935 with plants in India and the USA. Holds US DMFs for difelikefalin, icatibant and terlipressin. Pithampur FDA warning letter still open.
Harbin peptide API maker founded in 2011. Holds US DMFs for 11 peptide APIs. FDA issued it a CGMP warning letter in May 2026 that remains open.
Nanjing maker of peptide, protein and polysaccharide APIs and finished products, registered in 2017. Holds US DMFs for semaglutide and tirzepatide. FDA warning letter issued Nov 2026.
Mumbai-based generics group that makes APIs and finished medicines. Holds US Type II DMFs for 15 peptide APIs, including GLP-1s and GnRH analogues.
Mumbai drug maker with its own API and formulation plants in India. Holds US DMFs for 3 peptide APIs. Received an FDA CGMP warning letter in November 2026.
Large Zhejiang API and generic drug maker founded in 1989 and listed in Shanghai; holds active US DMFs for semaglutide and a semaglutide intermediate. It has an open FDA warning letter from June 2025.
Semaglutide (45), Tirzepatide (28), Liraglutide (20), Octreotide (20), Icatibant (13), Leuprolide (12).
No. FDA reviews a DMF only when a drug application references it, and it does not approve DMFs on their own. Check the holder's FDA inspection history and any warning letters as well.