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
Octreotide API manufacturers
Octreotide is a somatostatin analogue used for acromegaly and neuroendocrine tumours (Sandostatin).
20 listed companies hold an active US Type II Drug Master File for Octreotide API, based in India (7), China (4), Switzerland (2), Italy (2), Spain (1), Netherlands (1), United States (1), Greece (1), Taiwan (1). 16 have a regulator record of GMP manufacturing, and 3 carry an open FDA warning letter.
Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.
Octreotide API DMF holders (20)
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
Shilpa Pharma Lifesciences Ltd
HighRaichur, India
GMP
Raichur API and CDMO subsidiary of Shilpa Medicare; US DMFs for desmopressin, liraglutide and octreotide; Raichur units inspected by US FDA in 2025.
- Model
- CDMO
- Manufacturer?
- Yes
Sinopep-Allsino Biopharmaceutical Co., Ltd.
HighLianyungang, Jiangsu, China
GMP
Jiangsu peptide CDMO and generic API supplier with large automated SPPS capacity; states it has passed four US FDA inspections. Holds US DMFs for 9 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
TAPI NL B.V. (TAPI)
HighAmsterdam, Netherlands
GMP
Dutch holding entity of TAPI, Teva's API and CDMO business, with peptide development and GMP production across a global plant network. Holds US DMFs for 9 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
AmbioPharm
HighNorth Augusta, South Carolina, USA
GMPCOA
US peptide API CDMO with facilities in the US and China.
- 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
CBL Patras
HighPatras, Greece
GMPCOA
Greek peptide manufacturer producing GMP and non-GMP peptides and resins.
- 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
Fresenius Kabi iPSUM S.r.l.
HighVilladose (Rovigo), Italy
Fresenius Kabi's Italian API unit; its Villadose site near Venice develops and makes peptide APIs, also offered through Fresenius Kabi contract manufacturing. Holds US DMFs for 6 peptide APIs.
- Model
- CDMO
- 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
High
Suzhou peptide API and formulation maker founded in 2000, flagship of Tianma Pharma Group, offering CRO/CMO/CDMO services. Holds US DMFs for 8 peptide APIs.
- Model
- CDMO
- Manufacturer?
- Yes
Harbin Jixianglong Biotech Co., Ltd.
LowHarbin, China
GMP
Harbin peptide API maker founded in 2011. Holds US DMFs for 11 peptide APIs. FDA issued it a CGMP warning letter in May 2026 that remains open.
Notice: open regulatory issue
- 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
USV Private Limited
LowMumbai, India
GMP
Mumbai drug maker with its own API and formulation plants in India. Holds US DMFs for 3 peptide APIs. Received an FDA CGMP warning letter in November 2026.
Notice: open regulatory issue
- Model
- Manufacturer
- Manufacturer?
- Yes
Other peptide APIs
- Semaglutide API manufacturers (45)
- Tirzepatide API manufacturers (28)
- Liraglutide API manufacturers (20)
- Icatibant API manufacturers (13)
- Leuprolide API manufacturers (12)
- 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 Octreotide API?
Companies holding active US DMFs for Octreotide include Alembic Pharmaceuticals Ltd, Auro Peptides Ltd, BCN Peptides SA, Piramal Pharma Ltd (Piramal Pharma Solutions), Shilpa Pharma Lifesciences Ltd, Sinopep-Allsino Biopharmaceutical Co., Ltd., TAPI NL B.V. (TAPI), AmbioPharm, Bachem Holding AG, CBL Patras and 10 more. Other manufacturers may supply it without a US DMF.
Where are Octreotide API manufacturers based?
Among listed DMF holders: India (7), China (4), Switzerland (2), Italy (2), Spain (1), Netherlands (1), United States (1), Greece (1), Taiwan (1).
Do any Octreotide API holders have FDA warning letters?
Harbin Jixianglong Biotech Co., Ltd., Sun Pharmaceutical Industries Ltd and USV Private Limited have 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.