Alkem's API plant in Mandva receives US FDA approval

Alkem Labs Ltd’s active pharmaceutical ingredients (APIs) manufacturing plant at Mandva (Gujarat) has obtained the Establishment Inspection Report (EIR) from the US Food & Drug Administration (FDA). The plant was inspected by the US FDA in September 2015.
 
The API facility at Mandva will be Alkem’s sixth plant to receive US FDA approval. The company's other US FDA approved plants include formulation manufacturing facilities at Baddi (Himachal Pradesh), Daman and St Louis (Missouri, USA), and API manufacturing facilities at Ankleshwar (Gujarat) and California (USA).
 
Prabhat Agrawal, CEO, Alkem, said, "This development re-affirms Alkem's focus towards US as its key market and further boosts Alkem's ability to enhance its offering for this market."