Eptifibatide API manufacturers

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.

Eptifibatide API DMF holders (8)

Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.

TAPI NL B.V. (TAPI)
Amsterdam, Netherlands
High
GMP

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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
AmbioPharm
North Augusta, South Carolina, USA
High
GMPCOA

US peptide API CDMO with facilities in the US and China.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
Hybio Pharmaceutical
Shenzhen, China
High
GMP

Chinese peptide drug manufacturer producing APIs and finished products.

Model
Manufacturer
Manufacturer?
Yes
GMP CertifiedIn-House Production
PolyPeptide Group
Baar, Switzerland (sites in SE, BE, FR, US, IN)
High
GMPCOA

Peptide-focused CDMO running GMP manufacturing sites on three continents.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
High

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.

Model
Manufacturer
Manufacturer?
Yes
WholesaleInternational Shipping

Leshan-based peptide producer founded in 2015 with SPPS and LPPS lines; holds US DMFs for eptifibatide, semaglutide and tirzepatide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesaleCustom Synthesis
GMP

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.

Notice: open regulatory issue
Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesaleInternational Shipping
GMP

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.

Notice: open regulatory issue
Model
Manufacturer
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleInternational Shipping

Other peptide APIs

Related

Frequently asked questions

Who manufactures Eptifibatide API?

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.

Where are Eptifibatide API manufacturers based?

Among listed DMF holders: China (4), Netherlands (1), United States (1), Switzerland (1), India (1).

Do any Eptifibatide API holders have FDA warning letters?

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.

Does a DMF mean the API is FDA approved?

No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.