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
Calcitonin is a hormone peptide used for Paget's disease and hypercalcaemia.
5 listed companies hold an active US Type II Drug Master File for Calcitonin API, based in Switzerland (2), India (1), Spain (1), Italy (1). 4 have a regulator record of GMP manufacturing.
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.
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.
Privately owned Barcelona peptide CDMO founded in 1989, making GMP generic peptide APIs and custom NCE peptides. Holds US DMFs for 10 peptide APIs.
Swiss peptide and oligonucleotide CDMO with GMP plants in Europe and the US.
Peptide-focused CDMO running GMP manufacturing sites on three continents.
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.
Companies holding active US DMFs for Calcitonin include Auro Peptides Ltd, BCN Peptides SA, Bachem Holding AG, PolyPeptide Group and Fresenius Kabi iPSUM S.r.l.. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: Switzerland (2), India (1), Spain (1), Italy (1).
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.