Molecules / Leuprolide

Leuprolide API manufacturers

CAS 53714-56-0 ATC L02AE02 Updated 9 July 2026
16
manufacturers with an active filing 15 of them hold a US DMF or a CEP
219
finished-dose makers across 42 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Piramal Pharma

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

Holds one active US DMF for leuprolide, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

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

Chemi

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

Holds one active US DMF for leuprolide, filing since 2000. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
8 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Bachem

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

Holds one active US DMF for leuprolide, filing since 1998. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

Alembic Pharmaceuticals

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

Holds one active US DMF for leuprolide, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Bcn Peptides

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

Holds 2 active US DMFs for leuprolide, filing since 2012. 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
07

Auro Peptides

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

Holds one active US DMF for leuprolide, filing since 2016. 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
08

ScinoPharm Taiwan

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

Holds one active US DMF for leuprolide, filing since 2012. 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
09

Zhejiang Peptites Biotech

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

Holds one active US DMF for leuprolide, filing since 2020. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Matrix Pharmacorp

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

Holds one active US DMF for leuprolide, filing since 2017. 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
12

Anygen

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

US DMF
None on file
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
13

Aspen Oss

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

US DMF
None on file
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
15

Shanxi Tongda Pharmaceutical

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

Holds one active US DMF for leuprolide, 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
16

Mallinckrodt

Ireland
Makes the API

Registered with SFDA (Saudi Arabia) for leuprolide. Its GMP is recognised in 12 markets.

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

13 more manufacturers hold filings for leuprolide

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

PolyPeptide Laboratories (Sweden) ABAlembic PharmaceuticalsBcn PeptidesAuro PeptidesScinoPharm TaiwanZhejiang Peptites BiotechMatrix PharmacorpAlp Pharm BeijingAnygenAspen OssReali Tide Biological Technology (Weihai)Shanxi Tongda PharmaceuticalMallinckrodt
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Contract manufacturers (6)

Bachem Switzerland Dongkook Pharmaceutical South Korea Aspen API Netherlands CPC Scientific United States Omgene Life Sciences India PolyPeptide Sweden

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

Finished-dose makers (27)

Abbvie United States Amneal United States Sandoz Switzerland Gp Pharm Spain Zydus Lifesciences India Tolmar United States Recordati Industria Chimica e Farmaceutica Italy Baxalta Us United States Synthimed Labs India Zentiva, k.s Czech Republic Laboratorios Chalver De Colombia, S. A Colombia Casen Recordati, S.L Spain Bharat Serums and Vaccines India Orion Finland Pendopharm Canada Sanofi France Takeda Germany Mundipharma Germany Gufic Biosciences India Janssen-Cilag Farmaceutica Ltda Brazil

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

Who makes leuprolide?

Ask Fred which manufacturers are on record for leuprolide and what filings they hold.

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Also on this molecule

Recalls 1 Finished dose 27 Contract mfrs 6