Molecules / Ospemifene

Ospemifene API manufacturers

CAS 128607-22-7 ATC G03XC05 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
11
finished-dose makers across 8 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Alivus Life Sciences

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

Holds 2 active US DMFs for ospemifene, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Shionogi

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

Holds one active US DMF for ospemifene, filing since 2021. Its GMP is recognised in 12 markets.

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

Fermion Oy

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

Holds one active US DMF for ospemifene, filing since 2011. 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
04

Maithri Drugs

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

Holds one active US DMF for ospemifene, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Olon

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

Holds one active US DMF for ospemifene, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Honour Lab

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

Holds one active US DMF for ospemifene, filing since 2016. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Tianjin Weijie Pharmaceutical

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

Holds one active US DMF for ospemifene, filing since 2016. Its 2024 FDA inspection closed as VAI.

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

4 more manufacturers hold filings for ospemifene

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

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Finished-dose makers (1)

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 ospemifene?

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