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
Bortezomib API manufacturers
Bortezomib is a dipeptidyl boronic acid proteasome inhibitor used in multiple myeloma (Velcade).
7 listed companies hold an active US Type II Drug Master File for Bortezomib API, based in India (4), Netherlands (1), Taiwan (1), China (1). 5 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.
Bortezomib API DMF holders (7)
Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.
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
ScinoPharm Taiwan
HighTainan, Taiwan
GMP
API manufacturer and CDMO focused on complex generics, including peptides.
- Model
- CDMO
- Manufacturer?
- Yes
Biophore India Pharmaceuticals Pvt Ltd
HighHyderabad, India
GMP
Hyderabad API developer and maker founded in 2007, focused on niche and complex products. Holds US DMFs for cetrorelix, icatibant and sincalide.
- Model
- Manufacturer
- Manufacturer?
- Yes
Jiangsu Hansoh Pharmaceutical Group Co., Ltd
HighJiangsu, China
Main operating subsidiary of Hong Kong-listed Hansoh Pharma, founded 1995; holds US DMFs for degarelix and icatibant.
- Model
- Manufacturer
- Manufacturer?
- Yes
Reliance Life Sciences Pvt Ltd
MediumNavi Mumbai, India
Navi Mumbai biopharma and specialty pharma company; US DMFs for lanreotide and liraglutide.
- 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)
- 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)
- 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 Bortezomib API?
Companies holding active US DMFs for Bortezomib include Shilpa Pharma Lifesciences Ltd, TAPI NL B.V. (TAPI), ScinoPharm Taiwan, Biophore India Pharmaceuticals Pvt Ltd, Jiangsu Hansoh Pharmaceutical Group Co., Ltd, Reliance Life Sciences Pvt Ltd and Sun Pharmaceutical Industries Ltd. Other manufacturers may supply it without a US DMF.
Where are Bortezomib API manufacturers based?
Among listed DMF holders: India (4), Netherlands (1), Taiwan (1), China (1).
Do any Bortezomib 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.