Molecules / Etonogestrel

Etonogestrel API manufacturers

CAS 54048-10-1 ATC G03AC08 · Progestogens Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
10
shortage records on file across 5 countries
153
finished-dose makers across 39 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Industriale Chimica

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

Holds one active US DMF and one valid CEP for etonogestrel, filing since 2015. 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

“Gedeon Richter”

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

Holds one active US DMF for etonogestrel, filing since 1996. Its GMP is recognised in 28 markets.

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

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 etonogestrel, filing since 2017. 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
View profile
04

Sterling

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

Holds one active US DMF for etonogestrel, filing since 2011. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Aspen Oss

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

Holds one active US DMF for etonogestrel, filing since 1996.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Steroid

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

Holds one active US DMF for etonogestrel, filing since 2024.

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

3 more manufacturers hold filings for etonogestrel

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 (2)

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