Alembic Pharmaceuticals Ltd
HighVadodara, India
GMP
Vadodara drug maker, dating to 1907, with three API plants and six formulation plants. Holds US DMFs for 6 peptide APIs, including glatiramer and tirzepatide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Leuprolide API manufacturers
Leuprolide is a GnRH agonist used in prostate cancer and endometriosis (Lupron).
12 listed companies hold an active US Type II Drug Master File for Leuprolide API, based in India (5), Switzerland (2), China (2), Spain (1), Taiwan (1), Italy (1). 9 have a regulator record of GMP manufacturing, and 1 carries an open FDA warning letter.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Leuprolide API DMF holders (12)
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Auro Peptides Ltd
HighSangareddy (near Hyderabad), India
GMP
Peptide API subsidiary of Aurobindo Pharma with a plant near Hyderabad. Makes generic peptide APIs and runs GMP contract projects from mg to kg scale.
- Model
- CDMO
- Manufacturer?
- Yes
BCN Peptides SA
HighSant Quinti de Mediona (Barcelona), Spain
GMPISO
Privately owned Barcelona peptide CDMO founded in 1989, making GMP generic peptide APIs and custom NCE peptides. Holds US DMFs for 10 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
Piramal Pharma Ltd (Piramal Pharma Solutions)
HighNavi Mumbai, India
GMP
Indian CDMO whose Turbhe, Navi Mumbai site develops and makes peptide APIs by solid- and solution-phase synthesis. Holds US DMFs for 9 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
Bachem Holding AG
HighBubendorf, Switzerland
GMPCOA
Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.
- Model
- CDMO
- Manufacturer?
- Yes
PolyPeptide Group
HighBaar, Switzerland (sites in SE, BE, FR, US, IN)
GMPCOA
Peptide-focused CDMO running GMP manufacturing sites on three continents.
- Model
- CDMO
- Manufacturer?
- Yes
ScinoPharm Taiwan
HighTainan, Taiwan
GMP
API manufacturer and CDMO focused on complex generics, including peptides.
- Model
- CDMO
- Manufacturer?
- Yes
ALP Pharm Beijing Co., Ltd.
HighBeijing, China
Beijing API company, founded 2006, that holds DMFs and has its APIs made in partner facilities under its own quality control. Holds US DMFs for 13 peptide APIs.
- Model
- Manufacturer
- Manufacturer?
- Yes
Chemi S.p.A.
HighPatrica, Italy
Italian API maker in the Italfarmaco Group, founded 1973, producing peptides since 1996; US DMFs for leuprolide and octreotide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Hemmo Pharmaceuticals Pvt Ltd (Piramal Pharma Solutions)
HighNavi Mumbai, India
GMP
Mumbai peptide API maker acquired by Piramal Pharma in 2021; its oxytocin API is WHO-prequalified; US DMF for oxytocin.
- Model
- CDMO
- Manufacturer?
- Yes
ReaLi Tide Biological Technology (Weihai) Co., Ltd
MediumWeihai, China
Weihai Sino-US joint venture founded 2016 making peptide APIs and cosmetic peptides; US DMFs for leuprolide and semaglutide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Sun Pharmaceutical Industries Ltd
LowMumbai, India
GMP
Mumbai-based generics group that makes APIs and finished medicines. Holds US Type II DMFs for 15 peptide APIs, including GLP-1s and GnRH analogues.
Notice: open regulatory issue
- Model
- Manufacturer
- Manufacturer?
- Yes
Other peptide APIs
- Semaglutide API manufacturers (45)
- Tirzepatide API manufacturers (28)
- Liraglutide API manufacturers (20)
- Octreotide API manufacturers (20)
- Icatibant API manufacturers (13)
- Cetrorelix API manufacturers (11)
- Teriparatide API manufacturers (11)
- Desmopressin API manufacturers (10)
- Retatrutide API manufacturers (10)
- Lanreotide API manufacturers (9)
- Linaclotide API manufacturers (9)
- Bivalirudin API manufacturers (8)
- Difelikefalin API manufacturers (8)
- Eptifibatide API manufacturers (8)
- Ganirelix API manufacturers (8)
- Bortezomib API manufacturers (7)
- Degarelix API manufacturers (7)
- Oxytocin API manufacturers (7)
- Vasopressin API manufacturers (7)
- Glatiramer API manufacturers (6)
- Calcitonin API manufacturers (5)
- Carfilzomib API manufacturers (5)
- Caspofungin API manufacturers (5)
- Exenatide API manufacturers (5)
- Micafungin API manufacturers (5)
- Plecanatide API manufacturers (5)
- Etelcalcetide API manufacturers (4)
- Sincalide API manufacturers (4)
- Glucagon API manufacturers (3)
Related
Frequently asked questions
Who manufactures Leuprolide API?
Companies holding active US DMFs for Leuprolide include Alembic Pharmaceuticals Ltd, Auro Peptides Ltd, BCN Peptides SA, Piramal Pharma Ltd (Piramal Pharma Solutions), Bachem Holding AG, PolyPeptide Group, ScinoPharm Taiwan, ALP Pharm Beijing Co., Ltd., Chemi S.p.A., Hemmo Pharmaceuticals Pvt Ltd (Piramal Pharma Solutions) and 2 more. Other manufacturers may supply it without a US DMF.
Where are Leuprolide API manufacturers based?
Among listed DMF holders: India (5), Switzerland (2), China (2), Spain (1), Taiwan (1), Italy (1).
Do any Leuprolide API holders have FDA warning letters?
Sun Pharmaceutical Industries Ltd has an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.
Does a DMF mean the API is FDA approved?
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.