Semaglutide is a GLP-1 receptor agonist; the active ingredient of Novo Nordisk's Ozempic, Wegovy and Rybelsus.
45 listed companies hold an active US Type II Drug Master File for Semaglutide API, based in China (31), India (8), United States (2), Switzerland (2), Netherlands (1), United Arab Emirates (1). 22 have a regulator record of GMP manufacturing, and 4 carry an open FDA warning letter.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
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.
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.
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.
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-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.
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.
Chinese peptide drug manufacturer producing APIs and finished products.
Peptide-focused CDMO running GMP manufacturing sites on three continents.
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.
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.
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.
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.
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.
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.
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 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.
Weihai Sino-US joint venture founded 2016 making peptide APIs and cosmetic peptides; US DMFs for leuprolide and semaglutide.
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.
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.
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.
Companies holding active US DMFs for Semaglutide include Apicore LLC (RK Pharma), Asymchem Life Science (Tianjin) Co., Ltd, Auro Peptides Ltd, Biocon Ltd, Changzhou Pharmaceutical Factory (CPF), Chinese Peptide Company (CPC Scientific), FDC Limited, MSN Life Sciences Private Ltd (MSN Group), Piramal Pharma Ltd (Piramal Pharma Solutions), Sinopep-Allsino Biopharmaceutical Co., Ltd. and 35 more. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (31), India (8), United States (2), Switzerland (2), Netherlands (1), United Arab Emirates (1).
Harbin Jixianglong Biotech Co., Ltd., Nanjing Hanxin Pharmaceutical Technology Co., Ltd., Sun Pharmaceutical Industries Ltd and Zhejiang Huahai Pharmaceutical Co., Ltd. have an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.