Molecules / Cyproterone

Cyproterone API manufacturers

CAS 2098-66-0 ATC G03HA01 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
38
shortage records on file across 4 countries
238
finished-dose makers across 38 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Bayer

Germany
Makes the APIFinished dose

Holds 2 valid CEPs for cyproterone, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 22 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
22 markets
02

Cipla

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

Holds 4 valid CEPs for cyproterone, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
None on file
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced EDQM certificate database
View profile
03

Farmabios

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

Holds one active US DMF for cyproterone, filing since 2005. 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
View profile
05

Newchem

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

Holds one valid CEP for cyproterone, filing since 2023. Its 2023 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
06

Registered with SFDA (Saudi Arabia) for cyproterone. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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3 more manufacturers hold filings for cyproterone

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

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Contract manufacturers (4)

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 cyproterone?

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

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Sold in these combinations

Fixed-dose combinations containing cyproterone. Each page leads with the verified API makers of every component.