Semaglutide is a 31-amino acid GLP-1 receptor agonist approved by FDA under brand names Ozempic (injectable, type 2 diabetes), Wegovy (injectable, chronic weight management), and Rybelsus (oral tablet, type 2 diabetes). Novo Nordisk produces the peptide backbone by recombinant DNA technology in yeast and attaches the fatty-acid side chain chemically; generic API manufacturers generally use solid-phase or hybrid chemical synthesis. FDA-approved semaglutide products bear a boxed warning addressing the risk of thyroid C-cell tumors. In 2024-2025, the FDA issued over 50 warning letters targeting unauthorized semaglutide sales, with letters to Prime Vitality/Prime Peptides (December 2024), Xcel Research (December 2024), and USApeptide.com (February 2025) specifically citing unapproved semaglutide products marketed with therapeutic claims. Buyers sourcing semaglutide should verify that suppliers operate under registered FDA establishments with current GMP certification.
Directory listing last reviewed October 2026.
62 manufacturers hold an active Type II Drug Master File for SemaglutideAPI, taken from the FDA's quarterly DMF list; 33 of them are listed in this directory. A DMF lets a drug applicant reference the maker's manufacturing data. It is not an FDA approval. To ship GLP-1 API into the US, a manufacturer must also be on the FDA's Import Alert 66-80 green list, and not on the Import Alert 66-40 red list.
Request Semaglutide API quotes| Manufacturer | Location | US DMF | Filed |
|---|---|---|---|
| Zhejiang Peptites Biotech (ZPC) | China (Shengzhou, Zhejiang) | 35712, 42288, 43245, 43260 | 2021 |
| ALP Pharm Beijing | China (Beijing) | 35875 | 2021 |
| PolyPeptide Group | Global | 36101, 38177 | 2021 |
| Dr. Reddy's Laboratories | India | 36036 | 2021 |
| Sun Pharmaceutical IndustriesFDA import alert | India (Mumbai) | 36345 | 2021 |
| Zydus Lifesciences | India (Ahmedabad) | 36389 | 2021 |
| Sinopep Biopharma | China | 36273, 42796, 43275 | 2021 |
| JYMed Peptide | China (Shenzhen) | 36009, 41170, 41090, 42519 | 2022 |
| Bachem Holding AG | Switzerland / USA | 37594 | 2023 |
| Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd. | China | 38213 | 2023 |
| Hybio Pharmaceutical | China | 38443, 40319, 40534, 44328 | 2023 |
| Aurisco Pharmaceutical | China (Yangzhou) | 38479, 42525 | 2023 |
| MSN Laboratories | India (Hyderabad) | 38729 | 2023 |
| Chengdu Shengnuo BiopharmFDA import alert | China | 38424 | 2023 |
| Chinese Peptide Company (Medtide) | China (Hangzhou) | 39104 | 2023 |
| Asymchem | USA (NC) / China | 39091 | 2023 |
| Harbin Jixianglong BiotechFDA import alert | China (Harbin) | 39609 | 2024 |
| Fujian Genohope Biotech | China (Fujian) | 39522, 39932, 40957, 42491 | 2024 |
| Hangzhou Go Top Peptide Biotech Co., Ltd. | China | 39930 | 2024 |
| Nanjing Cellnuo Biopharmaceutical | China (Nanjing) | 39847 | 2024 |
| Hangzhou Thinheal Pharma-Tech Co.,Ltd | China (Hangzhou) | 39902, 43241 | 2024 |
| Apicore (RK Pharma) | USA (East Windsor, NJ) | 40124 | 2024 |
| Suzhou Ryway Biotech | China (Suzhou) | 40989 | 2024 |
| Biocon | India (Bengaluru) | 40714 | 2024 |
| Xiushi Biopharma | China (Nantong) | 41460, 44827 | 2025 |
| Suzhou Motif Biotech | China (Suzhou) | 41860 | 2025 |
| TAPI (Teva API) / Novetide | Israel / Global | 42108 | 2025 |
| Sichuan Duorui Biopharmaceutical | China (Chengdu) | 43251 | 2025 |
| El-Peptido (Shanghai) Biopharmaceutical | China (Shanghai) | 43425 | 2025 |
| Auro Peptides | India (Hyderabad) | 42442 | 2026 |
| Piramal Pharma Solutions | India (Mumbai) | 43801 | 2026 |
| FDC Limited | India (Mumbai) | 43785 | 2026 |
| Hetero | India (Hyderabad) | 44229 | 2026 |
Not yet listed in this directory, so we have not reviewed them. Names as printed in the FDA DMF list.
| DMF holder | US DMF | Filed |
|---|---|---|
| Ambio Inc | 36015 | 2021 |
| Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd | 38507 | 2023 |
| Beijing QL Biopharmaceutical Co Ltd | 38480 | 2023 |
| Chongqing Chen'An Biopharmaceutical Co Ltd | 38798 | 2023 |
| Wuhan More Biotechnology Co Ltd | 39115 | 2023 |
| Huisheng Biopharmaceutical Co Ltd | 39495 | 2024 |
| Shenzhen Readline Biotech Co Ltd | 39791 | 2024 |
| Ningbo Kunpeng Biotech Co Ltd | 40069 | 2024 |
| Guangdong Zetapharmax Co Ltd | 40212 | 2024 |
| Sichuan Qisheng Biomedical Technology Co Ltd | 40496 | 2024 |
| Nanjing Hanxin Pharmaceutical Technology Co Ltd | 39209 | 2024 |
| Zhejiang Zerui Biopharma Co Ltd | 40471 | 2024 |
| Anhui Taienkang Pharmaceutical Co Ltd | 41023 | 2024 |
| Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co Ltd | 40713 | 2025 |
| Shanxi Tongda Pharmaceutical Co Ltd | 40973 | 2025 |
| Anhui Poly Pharm Co Ltd | 41314 | 2025 |
| Sichuan Jisheng Biopharmaceutical Co Ltd | 41576 | 2025 |
| Ningxia Lanbosi Chemistry Technology Co Ltd | 41594 | 2025 |
| Reali Tide Biological Technology (Weihai) Co Ltd | 41187 | 2025 |
| Suzhou Lixin Pharmaceutical Co Ltd | 41945 | 2025 |
| Chongqing Sintaho Pharmaceutical Co Ltd | 42038 | 2025 |
| Changzhou Pharmaceutical Factory | 42883 | 2025 |
| Novoprotein Scientific (Shanghai) Inc | 43358 | 2025 |
| Chengdu Brilliant Biopharmaceutical Co Ltd | 43182 | 2026 |
| Taiji Group Chongqing Fuling Pharmaceutical Co Ltd | 43990 | 2026 |
| Virtu Pharmako (Zhejiang) Co Ltd | 44039 | 2026 |
| Lepu Pharmaceutical Co Ltd | 44008 | 2026 |
| Jilin Qijian Bio-Pharmaceutical Co Ltd | 44246 | 2026 |
| Zhejiang Huahai Pharmaceutical Co Ltd | 44386 | 2026 |
Compare all GLP-1 molecules on the GLP-1 API manufacturers page, or request API quotes from several manufacturers at once. Compare other molecules on the peptide API manufacturers index. Hold a Semaglutide DMF and not listed? Add your company.
Most of these are research-grade or wholesale vendors rather than API manufacturers. Ask any vendor which facility made the batch.