Molecules / Ethionamide

Ethionamide API manufacturers

CAS 536-33-4 ATC J04AD03 Updated 9 July 2026
5
manufacturers with an active filing 3 of them hold a US DMF or a CEP
42
finished-dose makers across 18 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Macleods Pharmaceuticals

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for ethionamide. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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02

Orgapharm Sas

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

Holds one active US DMF for ethionamide, filing since 2010. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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03

APICHEM Laboratories

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

Holds one active US DMF for ethionamide, filing since 2023. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Pen Tsao Chemical Industry

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

Holds one valid CEP for ethionamide, filing since 2024.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
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05

Registered with PMDA (Japan) for ethionamide.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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2 more manufacturers hold filings for ethionamide

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

Pen Tsao Chemical IndustryLiaoningBeiqiPharmaceuticalCo.,Ltd
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Finished-dose makers (4)

Cipla India Lupin India Micro Labs India 'Công ty cổ phần dược phẩm ME DI SUN Vietnam

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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