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
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.
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
Privately owned Barcelona peptide CDMO founded in 1989, making GMP generic peptide APIs and custom NCE peptides. Holds US DMFs for 10 peptide APIs.
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.
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.
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.
Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.
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.
Mumbai peptide API maker acquired by Piramal Pharma in 2021; its oxytocin API is WHO-prequalified; US DMF for oxytocin.
Navi Mumbai biopharma and specialty pharma company; US DMFs for lanreotide and liraglutide.
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.
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.
Among listed DMF holders: India (4), China (3), Spain (1), Switzerland (1).
Sun Pharmaceutical Industries Ltd has an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.