Molecules / Norgestrel

Norgestrel API manufacturers

CAS 6533-00-2 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
47
shortage records on file across 6 countries
39
finished-dose makers across 15 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Bayer S/A

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

Holds one active US DMF for norgestrel, filing since 2004. 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
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02

Lupin

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

Holds one active US DMF for norgestrel, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

“Gedeon Richter”

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

Holds 2 active US DMFs for norgestrel, filing since 1991. Its GMP is recognised in 28 markets.

US DMF
2 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
04

Sterling

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

Holds one active US DMF for norgestrel, filing since 2025. 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

Hunan KYF Pharmaceutical

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

Holds one active US DMF for norgestrel, filing since 2025. Its 2017 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2017 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers hold filings for norgestrel

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

SterlingHunan KYF Pharmaceutical
Open the full list with a free account

Contract manufacturers (6)

Bayer Germany Hubei Gedian humanwell Pharmaceutical China Acme Generics India Shree Venkatesh International India Montage Laboratories India Sikdar Medical United Kingdom

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

Finished-dose makers (10)

L Perrigo United States Senador Laboratories India Bayer Weimar Gmbh Und Germany Pfizer Brasil Ltda Brazil Viatris United States Mylan Dublin Ireland Par Laboratories 34 India Saffron Pharmaceuticals - India Pakistan Medoz Pharmaceuticals India Watson Laboratories United States

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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Also on this molecule

Shortages 47 Recalls 6 Finished dose 10 Contract mfrs 6