Molecules / Norgestimate

Norgestimate API manufacturers

CAS 35189-28-7 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
54
finished-dose makers across 8 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

03

Lupin

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

Holds one active US DMF for norgestimate, filing since 2009. 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
04

Industriale Chimica

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

Holds 2 active US DMFs and one valid CEP for norgestimate, filing since 2008. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
05

Gador S A

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

Holds one active US DMF for norgestimate, filing since 2002. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers hold filings for norgestimate

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

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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 norgestimate. Each page leads with the verified API makers of every component.