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.
- Model
- CDMO
- Manufacturer?
- Yes
Eptifibatide is a cyclic heptapeptide glycoprotein IIb/IIIa inhibitor (Integrilin).
8 listed companies hold an active US Type II Drug Master File for Eptifibatide API, based in China (4), Netherlands (1), United States (1), Switzerland (1), India (1). 6 have a regulator record of GMP manufacturing, and 2 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.
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.
US peptide API CDMO with facilities in the US and China.
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.
Leshan-based peptide producer founded in 2015 with SPPS and LPPS lines; holds US DMFs for eptifibatide, semaglutide and tirzepatide.
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.
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.
Companies holding active US DMFs for Eptifibatide include TAPI NL B.V. (TAPI), AmbioPharm, Hybio Pharmaceutical, PolyPeptide Group, ALP Pharm Beijing Co., Ltd., Sichuan Jisheng Biopharmaceutical Co., Ltd, Harbin Jixianglong Biotech Co., Ltd. and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (4), Netherlands (1), United States (1), Switzerland (1), India (1).
Harbin Jixianglong Biotech Co., Ltd. and Sun Pharmaceutical Industries 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.