Molecules / Tirofiban

Tirofiban API manufacturers

CAS 144494-65-5 ATC B01AC17 · Platelet aggregation inhibitors Updated 9 July 2026
5
manufacturers with an active filing 3 of them hold a US DMF or a CEP
2
shortage records on file across 2 countries
95
finished-dose makers across 30 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Gland Pharma

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

Holds one active US DMF for tirofiban, filing since 2009. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Wisdom Pharmaceutical

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

Holds one active US DMF for tirofiban, filing since 2018. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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03

Farmabios

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

Holds one active US DMF for tirofiban, filing since 2013. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Cadila Healthcare

India
Makes the API

Registered with SFDA (Saudi Arabia) for tirofiban. Its GMP is recognised in 7 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
7 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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05

Edmond Pharma

Italy
Makes the API

Registered with SFDA (Saudi Arabia) for tirofiban. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
5 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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2 more manufacturers hold filings for tirofiban

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Cadila HealthcareEdmond Pharma
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Contract manufacturers (1)

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)

Antibioticos Do Brasil Ltda Brazil Medac Gesellschaft für klinische Spezialpräparate mbH; Germany Altan Pharmaceuticals Spain Aspen South Africa Lunan Better Pharmaceutical China Caplin Point Laboratories India Jazeera Pharmaceutical Industries Saudi Arabia Laboratorio Libra Uruguay Sunny Taiwan Tabuk Pharmaceutical Manufacturing Saudi Arabia

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

Who makes tirofiban?

Ask Fred which manufacturers are on record for tirofiban and what filings they hold.

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Also on this molecule

Shortages 2 Recalls 4 Finished dose 10 Contract mfrs 1