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Biocon gets USFDA nod for generic product

Biocon Pharma Ltd, a subsidiary of Biocon, has received received approval of its ANDA for Mycophenolic Acid from the US drug regulator.

“Biocon Pharma, a subsidiary of the company, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolic Acid,” the company said in a regulatory filing.

This product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180 mg and 360 mg strengths.

“This approval further adds to Biocon’s portfolio of vertically integrated complex drug products,” the company said in a statement.

On Thursday, Biocon shares were down 1% to close at 367 apiece on NSE.

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