Molecules / Trimebutine

Trimebutine API manufacturers

CAS 39133-31-8 ATC A03AA05 Updated 9 July 2026
7
manufacturers with an active filing 5 of them hold a US DMF or a CEP
9
shortage records on file across 3 countries
174
finished-dose makers across 28 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hainan Poly Pharm

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

Holds one active US DMF for trimebutine, filing since 2020. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
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02

PMC Isochem

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

Holds 3 active US DMFs for trimebutine, filing since 2006. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
3 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
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03

Zhejiang East-Asia Pharmaceutical

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

Holds one valid CEP for trimebutine, filing since 2024. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
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04

Moehs

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

Holds one valid CEP for trimebutine, filing since 2025. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
05

Zach System

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

Holds one valid CEP for trimebutine, filing since 2025. Its 2021 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
06

Registered with DAV (Vietnam) for trimebutine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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07

Vacopharm Pharmaceutical Joint Stock

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for trimebutine. Its GMP is recognised in 1 market.

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

4 more manufacturers hold filings for trimebutine

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

MoehsZach SystemCông ty TNHH Liên doanh Hasan - DermapharmVacopharm Pharmaceutical Joint Stock
Open the full list with a free account

Contract manufacturers (2)

Moehs Ibérica, S.L Spain Santa Farma Ílaç San Turkey

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

Finished-dose makers (43)

Apotex Canada Viatris United States Zentiva, k.s Czech Republic Pfizer Brasil Ltda Brazil AlfaSigma Italy Eurofarma Laboratorios Brazil Pfizer United States Sandoz Switzerland Italfarmaco Italy Macleods Pharmaceuticals India Mint Pharmaceuticals Canada Zydus Lifesciences India Global Napi Pharmaceuticals Egypt Aché Laboratorios Farmacéuticos S. A Brazil Ems S/A Brazil Germed Farmaceutica Ltda Brazil Kyongbo Pharmaceutical South Korea Laboratorios Andrómaco Chile Zaklady Farmaceutyczne Polpharma Poland C.I. Farmacapsulas Colombia

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

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Also on this molecule

Shortages 9 Recalls 5 Finished dose 43 Contract mfrs 2