API SOURCING · FDA DMF LIST, Q3 2026

Peptide API Manufacturers

113 manufacturers hold an active US Drug Master File for at least one of 44 peptide APIs. 56 of them are listed in this directory with a reviewed profile. Pick a molecule to compare its DMF holders, filing years and FDA import alert status.

How to read this:DMF holders come from the FDA's quarterly list of Drug Master Files, active Type II (drug substance) files only. A filed DMF lets a finished-drug applicant reference the manufacturer's data; it is not FDA approval. Intermediates, devices and finished dosage forms are left out.
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Peptide APIUS DMF holdersListed hereDMFs filed
Semaglutide API manufacturers62332021–2026
Tirzepatide API manufacturers34272023–2026
Liraglutide API manufacturers22192013–2026
Octreotide API manufacturers22202000–2026
Leuprolide API manufacturers17131993–2025
Icatibant API manufacturers16142007–2024
Linaclotide API manufacturers14122011–2026
Retatrutide API manufacturers13112025–2026
Teriparatide API manufacturers1392015–2025
Eptifibatide API manufacturers12102005–2026
Lanreotide API manufacturers12102010–2025
Bivalirudin API manufacturers11102007–2018
Cetrorelix API manufacturers11102005–2025
Difelikefalin API manufacturers1082023–2026
Desmopressin API manufacturers991990–2026
Ganirelix API manufacturers991999–2024
Vasopressin API manufacturers982012–2026
Degarelix API manufacturers862019–2025
Glatiramer API manufacturers742012–2026
Oxytocin API manufacturers761993–2024
Calcitonin API manufacturers651986–2023
Plecanatide API manufacturers662019–2025
Etelcalcetide API manufacturers552020–2026
Exenatide API manufacturers552006–2020
Sincalide API manufacturers552000–2025
Teduglutide API manufacturers532016–2026
Terlipressin API manufacturers442019–2026
Abaloparatide API manufacturers332020–2023
Glucagon API manufacturers322005–2022
Goserelin API manufacturers322015–2024
Thymalfasin API manufacturers332024–2026
Triptorelin API manufacturers331986–2024
Atosiban API manufacturers212024–2026
Cagrilintide API manufacturers222026
Gonadorelin API manufacturers221993–2020
Nesiritide API manufacturers222012–2013
Sermorelin API manufacturers222026
Setmelanotide API manufacturers222025–2026
Bremelanotide API manufacturers112026
Carbetocin API manufacturers112024
Histrelin API manufacturers112003
Pramlintide API manufacturers112018
Secretin API manufacturers112001
Vosoritide API manufacturers112025

Which manufacturers hold the most peptide API DMFs?

Among listed manufacturers, these hold active US DMFs for the widest range of peptide APIs. Breadth is not quality: check each profile for FDA inspection history and open import alerts.

  1. Hybio Pharmaceutical (China): 19 APIs
  2. Auro Peptides (India (Hyderabad)): 15 APIs
  3. Bachem Holding AG (Switzerland / USA): 15 APIs
  4. Chengdu Shengnuo Biopharm (China): 15 APIsFDA action
  5. Sun Pharmaceutical Industries (India (Mumbai)): 15 APIsFDA action
  6. ALP Pharm Beijing (China (Beijing)): 14 APIs
  7. Harbin Jixianglong Biotech (China (Harbin)): 13 APIsFDA action
  8. MSN Laboratories (India (Hyderabad)): 12 APIs
  9. PolyPeptide Group (Global): 12 APIs
  10. Sinopep Biopharma (China): 11 APIs
  11. BCN Peptides (Spain (Barcelona)): 10 APIs
  12. Piramal Pharma Solutions (India (Mumbai)): 9 APIs
  13. TAPI (Teva API) / Novetide (Israel / Global): 9 APIs
  14. Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd. (China): 8 APIs
  15. Dr. Reddy's Laboratories (India): 7 APIs

What this list does and does not cover

A missing manufacturer may still hold a European CEP, a Japanese or Chinese registration, or supply markets outside the US. Antibiotic and antifungal peptides, cyclosporine and radiopharmaceuticals are not included. Unlisted holders appear on each molecule page under the name printed in the FDA list, without review.

Hold a peptide API DMF and not listed? Add your company, or email hello@peptidesuppliers.tech with a correction.