Miglustat
Overview
Miglustat is an oral drug used primarily for the treatment of type 1 Gaucher disease and Niemann-Pick disease type C. It functions by inhibiting the enzyme glucosylceramide synthase, reducing the substrate accumulation that characterizes these disorders.
API suppliers (4)
Suppliers of Miglustat evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 3 of 4 suppliers.
1 of 4 holds a GMP certificate on record in the EU or UK registers
- DIPHARMA SASwitzerland1 active DMF GMP on record
- MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
- NAVINTA LLCUnited States1 active DMF
- APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (5 approved US products), the latest listed US patent on Miglustat expires 16 Sept 2038 and exclusivity 28 Sept 2026. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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