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Biotechnology major Biocon gets USFDA approval for generic product

The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant

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Biocon | Biocon USFDA approval | USFDA

Press Trust of India  |  New Delhi 

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Biotechnology major on Thursday said its unit has received approval from the US health regulator to market a generic product.

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.

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

This approval further adds to Biocon's portfolio of vertically integrated complex drug products, the company noted.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Thu, December 02 2021. 21:40 IST
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