Carfilzomib is a tetrapeptide epoxyketone proteasome inhibitor used in multiple myeloma (Kyprolis).
5 listed companies hold an active US Type II Drug Master File for Carfilzomib API, based in China (3), Netherlands (1), India (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.
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.
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.
Hyderabad API developer and maker founded in 2007, focused on niche and complex products. Holds US DMFs for cetrorelix, icatibant and sincalide.
Chongqing API maker founded in 2016 covering high-potency APIs, peptides and XDC compounds with CDMO services; reports FDA on-site inspections in 2024 and 2025 and holds a US DMF for semaglutide.
Main operating subsidiary of Hong Kong-listed Hansoh Pharma, founded 1995; holds US DMFs for degarelix and icatibant.
Companies holding active US DMFs for Carfilzomib include Sichuan Huiyu Pharmaceutical Co., Ltd., TAPI NL B.V. (TAPI), Biophore India Pharmaceuticals Pvt Ltd, Chongqing Sintaho Pharmaceutical Co., Ltd. and Jiangsu Hansoh Pharmaceutical Group Co., Ltd. Other manufacturers may supply it without a US DMF.
Among listed DMF holders: China (3), Netherlands (1), India (1).
No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.