Molecules / Ganirelix

Ganirelix API manufacturers

CAS 124904-93-4 ATC H01CC01 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
9
shortage records on file across 5 countries
109
finished-dose makers across 29 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hybio Pharmaceutical

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

Holds one active US DMF for ganirelix, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Bcn Peptides

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

Holds 2 active US DMFs for ganirelix, filing since 2015. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Auro Peptides

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

Holds one active US DMF for ganirelix, filing since 2021. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Apicore Pharmaceuticals

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

Holds one active US DMF for ganirelix, filing since 2022. 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
05

Chengdu Shengnuo Biopharm

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

Holds one active US DMF for ganirelix, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Anygen

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

Holds one active US DMF for ganirelix, 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
07

Aspen Oss

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

Holds one active US DMF for ganirelix, filing since 1999.

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

4 more manufacturers hold filings for ganirelix

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

Apicore PharmaceuticalsChengdu Shengnuo BiopharmAnygenAspen Oss
Open the full list with a free account

Contract manufacturers (3)

Zhejiang Peptites Biotech China Gp Pharm Spain Omgene Life Sciences India

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

Finished-dose makers (14)

Fresenius Kabi Ab Sweden Ferring Germany Amphastar Nanjing United States Lupin India “Gedeon Richter” Hungary Synthimed Labs India Qilu Pharmaceutical China Gp Pharm Spain Organon Usa United States N.V. Organon; Netherlands Tris Pharma United States Labatec Pharma Switzerland Besins Healthcare Brazil Chemical Works Of Gedeon Richter Hungary

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 9 Recalls 3 Finished dose 14 Contract mfrs 3