Molecules / Levonorgestrel

Levonorgestrel API manufacturers

CAS 797-63-7 ATC G03AC03 · Progestogens Updated 9 July 2026
17
manufacturers with an active filing 14 of them hold a US DMF or a CEP
47
shortage records on file across 6 countries
915
finished-dose makers across 55 regulators
Showing 17 of 17 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Lupin

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

Holds one active US DMF and 2 valid CEPs for levonorgestrel, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
02

“Gedeon Richter”

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

Holds one active US DMF and one valid CEP for levonorgestrel, filing since 1990. Its GMP is recognised in 28 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
28 markets
04

Bayer S/A

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

Holds one active US DMF for levonorgestrel, filing since 1981. 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
06

Bayer

Germany
Makes the APIFinished dose

Holds one valid CEP for levonorgestrel, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 22 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
22 markets
How this listing is sourced EDQM certificate database
View profile
07

Cipla

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

Holds one active US DMF for levonorgestrel, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Formosa Laboratories

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

Holds one active US DMF for levonorgestrel, filing since 2008. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

ScinoPharm Taiwan

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

Holds one active US DMF for levonorgestrel, filing since 2003. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Hunan KYF Pharmaceutical

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

Holds one active US DMF for levonorgestrel, filing since 2022. 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
11

Symbiotec Pharmalab

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

Holds one active US DMF for levonorgestrel, filing since 2014. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Valary Lab

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

Holds 3 active US DMFs for levonorgestrel, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Hubei Gedian humanwell Pharmaceutical

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

Holds one active US DMF for levonorgestrel, filing since 2022. 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
15

Agimexpharm Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for levonorgestrel. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Công ty Cổ phần Nam Dược

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for levonorgestrel. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Cty Tnhh Dược Phẩm Usa-Nic

Vietnam
Makes the API

Registered with DAV (Vietnam) for levonorgestrel.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

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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