Romidepsin
Overview
Romidepsin is a cyclic peptide inhibitor of histone deacetylase, used in the treatment of various types of cancer, including cutaneous T-cell lymphoma. It works by increasing the acetylation of histone proteins, leading to cell cycle arrest and apoptosis in cancer cells.
API suppliers (4)
Suppliers of Romidepsin evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
3 of 4 hold a GMP certificate on record in the EU or UK registers
- CONCORD BIOTECH LTDIndia1 active DMF GMP on record
- TAPI NL BVNetherlands1 active DMF
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
- Zhejiang Hisun Pharmaceutical Co., Ltd.China GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (3 approved US products), the latest listed US patent on Romidepsin expires — and exclusivity 7 Dec 2026. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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