Accord BioPharma, the US speciality division of Intas Pharmaceuticals, has secured approval from the US Food and Drug Administration (FDA) for HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab).
Intas Pharmaceuticals is on FDA Import Alert List
Intas Pharmaceuticals, a leading multinational pharmaceutical company in India, has announced a strategic exclusive licensing agreement with Spanish company mAbxience (a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) for a biosimilar for Etanercept.
USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant
Drug manufacturer Intas Pharmaceuticals is no stranger to FDA scrutiny. Now, one of its plants has been placed on an import alert after a series of interactions with the agency.
Intas Pharmaceuticals Limited Receives FDA Warning Letter
Intas Pharmaceuticals Limited on FDA Import Alert List
USFDA issues warning letter to Intas Pharma for Sanand plant
Intas Pharmaceuticals Receives FDA Warning Letter