First new chemical entity discovered by Indian scientists gets USFDA approval
Rhizen has retained commercialisation rights for India while also being the manufacturing and supply partner for Umbralisib. Alembic owns 50 per cent stake in Rhizen
PB Jayakumar | February 9, 2021 | Updated 12:10 IST
Umbralisib receives USFDA approval
Umbralisib, a novel cancer drug discovered and out-licensed by India s Alembic Pharmaceuticals and its associate drug discovery company Rhizen Pharmaceuticals, has received the drug regulatory approval for sales in the US market. The drug is touted to be the first new chemical entity (NCE) discovered by Indian scientists to secure a US Food and Drug Administration (FDA) approval.