Lanreotide API manufacturers

Lanreotide is a long-acting somatostatin analogue (Somatuline Depot).

9 listed companies hold an active US Type II Drug Master File for Lanreotide API, based in India (4), China (3), Spain (1), Switzerland (1). 7 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.

Lanreotide API DMF holders (9)

Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.

BCN Peptides SA
Sant Quinti de Mediona (Barcelona), Spain
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
GMP

Neijiang, Sichuan injectables and API maker founded in 2010, listed on Shanghai's STAR Market, with FDA and UK MHRA GMP inspections; holds an active US DMF for lanreotide.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedFDA InspectedCDMO ServicesUS DMF HolderInjectables
High
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
Bachem Holding AG
Bubendorf, Switzerland
High
GMPCOA

Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionInternational Shipping
High

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
WholesaleInternational Shipping
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
GMP CertifiedIn-House ProductionWholesaleCDMO
Medium

Navi Mumbai biopharma and specialty pharma company; US DMFs for lanreotide and liraglutide.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
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
GMP CertifiedIn-House ProductionWholesaleInternational Shipping

Other peptide APIs

Related

Frequently asked questions

Who manufactures Lanreotide API?

Companies holding active US DMFs for Lanreotide include BCN Peptides SA, Piramal Pharma Ltd (Piramal Pharma Solutions), Sichuan Huiyu Pharmaceutical Co., Ltd., Sinopep-Allsino Biopharmaceutical Co., Ltd., Bachem Holding AG, ALP Pharm Beijing Co., Ltd., Hemmo Pharmaceuticals Pvt Ltd (Piramal Pharma Solutions), Reliance Life Sciences Pvt Ltd and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.

Where are Lanreotide API manufacturers based?

Among listed DMF holders: India (4), China (3), Spain (1), Switzerland (1).

Do any Lanreotide 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.