Molecules / Mifepristone

Mifepristone API manufacturers

CAS 84371-65-3 ATC G03XB01 Updated 9 July 2026
6
manufacturers with an active filing 4 of them hold a US DMF or a CEP
2
shortage records on file across 1 countries
138
finished-dose makers across 34 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Curia Spain S.A.U

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

Holds one active US DMF for mifepristone, filing since 2022. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

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

Formosa Laboratories

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

Holds one active US DMF for mifepristone, filing since 2013. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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03

Naari Pte

Singapore
Makes the APIFinished dose

Holds one active US DMF for mifepristone, filing since 2022. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
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05

Công ty Cổ phần Nam Dược

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for mifepristone. 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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06

Agimexpharm Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for mifepristone. 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

3 more manufacturers hold filings for mifepristone

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

zhejiang xianju pharmaceuticalCông ty Cổ phần Nam DượcAgimexpharm Pharmaceutical
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Contract manufacturers (3)

Hubei Gedian humanwell Pharmaceutical China Acme Generics India Shree Venkatesh International India

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

Finished-dose makers (23)

Teva Israel Synthimed Labs India ACME Formulation India Evita Solutions United States Viatris United States "West-Coast Pharmaceutical Works India Acme Generics India Centurion Laboratories India Synokem-Pharmaceuticals-Limited India Accent Pharmaceuticals Diagnostics India Công ty cổ phần sinh học dược phẩm Ba Đình Vietnam Armephaco Vietnam Binh Dinh Pharmaceutical And Medical Equipment Joint Stock Company Bidiphar Vietnam Công Ty TNHH Dược Phẩm Hạnh Thái Vietnam Công Ty TNHH Liên Doanh Stellapharm Vietnam Công ty Cổ phần Dược phẩm Sao Kim Vietnam Công ty TNHH Liên Doanh Stellapharm - Chi nhánh 1 Vietnam Công ty TNHH US Pharma USA Vietnam Công ty cổ phần dược Danapha Vietnam Công ty cổ phần dược phẩm Trường Thọ 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

Who makes mifepristone?

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

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Also on this molecule

Shortages 2 Finished dose 23 Contract mfrs 3