Tacrolimus

Overview

Tacrolimus is an immunosuppressive drug primarily used to reduce the risk of organ transplant rejection. It acts by inhibiting T-lymphocyte activation.

API suppliers (18)

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

• CONCORD BIOTECH LTDIndia2 active DMF GMP on record
• Biocon LimitedIndia2 active DMF
• LUNAN NEW TIME BIO-TECH CO LTD1 active DMF
• HISUN PHARMACEUTICAL HANGZHOU CO LTD1 active DMF
• Apotex Inc.Canada1 active DMF
• TAPI NL BVNetherlands1 active DMF
• HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDChina1 active DMF
• NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDChina1 active DMF GMP on record
• LEK PHARMACEUTICALS DD1 active DMF GMP on record
• CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD1 active DMF GMP on record
• FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)India1 active DMF
• CHENGDU YACHT BIOTECHNOLOGY CO LTD1 active DMF
• Guangdong Blue Treasure Pharmaceuticals Co. Ltd.China1 active DMF
• FARMHISPANIA SASpain1 active DMF
• Wuxi Fortune Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• JOYANG LABORATORIESChina
• HANGZHOU HUADONG MEDICINE GROUP BIOTECHNOLOGY INSTITUTE CO LTD
• ANTIBIOTICOS SPA

Patent & exclusivity (US)

Per the FDA Orange Book (58 approved US products), the latest listed US patent on Tacrolimus expires 30 Aug 2028 and exclusivity 16 Jul 2028. Generic API sourcing typically opens up once these lapse.

Therapeutic areas