Molecules / Dienogest

Dienogest API manufacturers

CAS 65928-58-7 ATC G03DB08 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
8
shortage records on file across 3 countries
449
finished-dose makers across 53 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Industriale Chimica

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

Holds one active US DMF and one valid CEP for dienogest, filing since 2010. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
02

Sterling

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

Holds one active US DMF and one valid CEP for dienogest, filing since 2022. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
3 markets
03

Bayer S/A

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

Holds one active US DMF for dienogest, filing since 1999. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
46 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Newchem

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

Holds one active US DMF and one valid CEP for dienogest, filing since 2023. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
05

“Gedeon Richter”

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

Holds one valid CEP for dienogest, filing since 2026. Its GMP is recognised in 28 markets.

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

Laborchemie Apolda

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

Holds one active US DMF for dienogest, filing since 2011. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dienogest, filing since 2023. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

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

4 more manufacturers hold filings for dienogest

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

Open the full list with a free account

Contract manufacturers (3)

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

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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Sold in these combinations

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