Ensifentrine

3 API suppliersSmall Molecule

Overview

Ensifentrine is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL4594287).

API suppliers (3)

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

Where these suppliers are
India1USA1

Country recorded for 2 of 3 suppliers.

1 of 3 holds a GMP certificate on record in the EU or UK registers

  • MSN LIFE SCIENCES PRIVATE LIMITEDIndia1 active DMF GMP on record
  • BREATHGREEN PHARMACEUTICAL CO LTD1 active DMF
  • Cipla USA, Inc.USA1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Ensifentrine expires 25 Jun 2044 and exclusivity 26 Jun 2029. Generic API sourcing typically opens up once these lapse.

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