Molecules / Eptifibatide

Eptifibatide API manufacturers

CAS 188627-80-7 ATC B01AC16 · Platelet aggregation inhibitors Updated 9 July 2026
10
manufacturers with an active filing 9 of them hold a US DMF or a CEP
8
shortage records on file across 3 countries
57
finished-dose makers across 23 regulators
Showing 10 of 10 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hybio Pharmaceutical

China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eptifibatide, filing since 2012. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eptifibatide, filing since 2005. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
03
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eptifibatide, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Chengdu Shengnuo Biopharm

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eptifibatide, filing since 2013. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Ambiopharm

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eptifibatide, filing since 2011. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Wuxi Kaili Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eptifibatide, filing since 2012.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Zhejiang Tasln Biopharma

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eptifibatide, filing since 2026.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Sinopep-Allsino Biopharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for eptifibatide. Its 2024 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

7 more manufacturers hold filings for eptifibatide

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Chengdu Shengnuo BiopharmAmbiopharmAlp Pharm BeijingSichuan Jisheng BiopharmaceuticalWuxi Kaili PharmaceuticalZhejiang Tasln BiopharmaSinopep-Allsino Biopharmaceutical
Open the full list with a free account

Contract manufacturers (3)

Zhejiang Peptites Biotech China Shenzhen Jymed Technology China Vem Ilac Sanayi Ve Ticaret A S Turkey

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (10)

Viatris United States Teva Israel Gland Pharma India Merck Sharp & Dohme Farmaceutica Ltda Brazil Omega Laboratories Canada Sagent Pharmaceuticals United States USV India Hainan Poly Pharm China Baxter Healthcare United States Rising United States

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Map eptifibatide for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Shortages 8 Recalls 2 Finished dose 10 Contract mfrs 3

By country

China 14