Tirzepatide is a 39-amino acid dual GIP and GLP-1 receptor agonist approved by FDA under brand names Mounjaro (type 2 diabetes) and Zepbound (chronic weight management). Manufactured by Eli Lilly, tirzepatide was the first approved dual incretin receptor agonist with Phase 3 SURPASS and SURMOUNT trials demonstrating efficacy in glycemic control and weight reduction. Tirzepatide was cited in FDA warning letters to USApeptide.com (February 2025) for unauthorized sales, with the FDA noting that no approved applications exist for the unapproved versions offered online. The agency's September 2025 wave of 50+ warning letters specifically targeted compounders claiming their tirzepatide products were generic versions or contained the same active ingredient as FDA-approved products. Only FDA-registered manufacturers with approved applications may legally distribute tirzepatide.
Directory listing last reviewed October 2026.
34 manufacturers hold an active Type II Drug Master File for TirzepatideAPI, taken from the FDA's quarterly DMF list; 27 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 Tirzepatide API quotes| Manufacturer | Location | US DMF | Filed |
|---|---|---|---|
| ALP Pharm Beijing | China (Beijing) | 38773 | 2023 |
| Sinopep Biopharma | China | 39465 | 2024 |
| Harbin Jixianglong BiotechFDA import alert | China (Harbin) | 39611 | 2024 |
| Zhejiang Peptites Biotech (ZPC) | China (Shengzhou, Zhejiang) | 39655, 42981 | 2024 |
| Hybio Pharmaceutical | China | 40156, 44429 | 2024 |
| Hangzhou Thinheal Pharma-Tech Co.,Ltd | China (Hangzhou) | 39900, 43231 | 2024 |
| JYMed Peptide | China (Shenzhen) | 40115 | 2024 |
| Apicore (RK Pharma) | USA (East Windsor, NJ) | 40123 | 2024 |
| Fujian Genohope Biotech | China (Fujian) | 40503 | 2024 |
| Hangzhou Apextide Biomedical | China (Hangzhou) | 40481 | 2024 |
| Suzhou Ryway Biotech | China (Suzhou) | 41066 | 2024 |
| Suzhou Motif Biotech | China (Suzhou) | 41036 | 2025 |
| Nanjing Cellnuo Biopharmaceutical | China (Nanjing) | 41650 | 2025 |
| Hangzhou Hotide Biotech | China (Hangzhou) | 41744 | 2025 |
| Biocon | India (Bengaluru) | 43038 | 2025 |
| Chengdu Shengnuo BiopharmFDA import alert | China | 42445 | 2025 |
| Sichuan Duorui Biopharmaceutical | China (Chengdu) | 43257 | 2025 |
| TAPI (Teva API) / Novetide | Israel / Global | 42369 | 2025 |
| Guizhou Utide Biotechnology | China (Zunyi, Guizhou) | 42984 | 2025 |
| El-Peptido (Shanghai) Biopharmaceutical | China (Shanghai) | 43426 | 2025 |
| Aurisco Pharmaceutical | China (Yangzhou) | 41816 | 2025 |
| MSN Laboratories | India (Hyderabad) | 43540 | 2026 |
| Alembic Pharmaceuticals | India (Vadodara) | 43203 | 2026 |
| Xiushi Biopharma | China (Nantong) | 43983 | 2026 |
| Dr. Reddy's Laboratories | India | 43800 | 2026 |
| Chinese Peptide Company (Medtide) | China (Hangzhou) | 43979 | 2026 |
| Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd. | China | 44306 | 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 |
|---|---|---|
| Shanghai Jingmai Pharmaceutical Science & Technology Co Ltd | 40166 | 2024 |
| Sichuan Qisheng Biomedical Technology Co Ltd | 40495 | 2024 |
| Shenzhen Alvantis Pharma Co Ltd | 40668 | 2024 |
| Nanjing Hanxin Pharmaceutical Technology Co Ltd | 40378 | 2024 |
| Sichuan Jisheng Biopharmaceutical Co Ltd | 41523 | 2025 |
| Ningxia Labschem Co Ltd | 42259 | 2025 |
| Changzhou Pharmaceutical Factory | 43153 | 2025 |
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 Tirzepatide 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.