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Biocon gets USFDA nod for generic product

Biocon gets USFDA nod for generic product

The 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 This approval further adds to Biocon's portfolio of vertically integrated complex drug products

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

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. ANDA is data to submit to the US FDA for approval of new generic medicines.

The 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 noted.

Meanwhile, Biocon said on Wednesday that it has been selected for the Dow Jones Sustainability Index (DJSI) in the Emerging Markets (EM) category for its Environmental, Social and Governance (ESG) practices.

The pharma major made a formal submission for Corporate Sustainability Assessment for its listing on the DJSI for the first time this year and made it to the DJSI EM Index with a total sustainability score of 45 as against an industry average of 18, achieving a 93rd percentile position.

It is among the top 15 companies from India and one of the 12 companies from the pharmaceuticals, biotechnology and life sciences sectors to be featured in the index for 2021. A total of 360 Indian companies were invited to participate in DJSI in 2021.

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