Alkem's Mandva plant gets establishment nod from USFDA
New Delhi: Drug firm Alkem Labs Ltd said one of its manufacturing plants in Gujarat has obtained the Establishment Inspection Report (EIR) "approval" from US health regulator USFDA.
"Its manufacturing plant at Mandva, Gujarat, has successfully obtained the Establishment Inspection Report from the USFDA. The plant manufactures Active Pharmaceutical Ingredients (APIs) and was inspected by the USFDA in September 2015," Alkem Labs said in a BSE filing.
It further said: "The facility at Mandva would be Alkem's sixth plant to receive USFDA approval."
"The development re-affirms Alkem's focus towards US as its key market and further boost Alkem's ability to enhance its product offering in the market," Alkem Labs CEO Prabhat Aggarwal said.
The company's other USFDA approved plants include formulation manufacturing facilities at Baddi in Himachal Pradesh, Daman and St Louis in the US and API manufacturing facilities at Ankleshwar in Gujarat and California in the US.
"Its manufacturing plant at Mandva, Gujarat, has successfully obtained the Establishment Inspection Report from the USFDA. The plant manufactures Active Pharmaceutical Ingredients (APIs) and was inspected by the USFDA in September 2015," Alkem Labs said in a BSE filing.
It further said: "The facility at Mandva would be Alkem's sixth plant to receive USFDA approval."
"The development re-affirms Alkem's focus towards US as its key market and further boost Alkem's ability to enhance its product offering in the market," Alkem Labs CEO Prabhat Aggarwal said.
The company's other USFDA approved plants include formulation manufacturing facilities at Baddi in Himachal Pradesh, Daman and St Louis in the US and API manufacturing facilities at Ankleshwar in Gujarat and California in the US.
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