Mitomycin

Overview

Mitomycin is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL105).

API suppliers (8)

Suppliers of Mitomycin evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• HUBEI HONCH PHARMACEUTICAL CO LTD1 active DMF
• Wuxi Fortune Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• CHEMWERTH INCFrance1 active DMF
• Zhejiang Hisun Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• TAPI NL BVNetherlands1 active DMF
• CONCORD BIOTECH LTDIndia1 active DMF GMP on record
• KYOWA HAKKO KOGYO CO LTD
• MICROBIOPHARM JAPAN CO LTDJapan GMP on record

EU CEP holders (4)

Companies holding a valid EU Certificate of Suitability (CEP) for Mitomycin, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (22 approved US products), the latest listed US patent on Mitomycin expires 20 Jan 2031 and exclusivity 12 Jun 2028. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

[(4S,6S,7R,8S)-11-amino-7-methoxy-12-methyl-10,13-dioxo-2,5-diazatetracyclo[7.4.0.02,7.04,6]trideca-1(9),11-dien-8-yl]methyl carbamate

Canonical SMILES

CC1=C(C(=O)C2=C(C1=O)N3C[C@H]4[C@@H]([C@@]3([C@@H]2COC(=O)N)OC)N4)N

InChIKey

NWIBSHFKIJFRCO-WUDYKRTCSA-N