Biocon gets USFDA nod for generic product

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.

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.

  • Related Posts

    35 drugs manufactured in Telangana fail CDSCO quality checks

    Hyderabad:  As many as 35 drugs manufactured in Telangana and supplied to states including Himachal Pradesh and Uttarakhand were flagged over the past year by the Central Drugs Standard Control…

    Delhi govt inspects 25 firms, collects 55 samples in crackdown on spurious anticancer drugs

    New Delhi:  In a special enforcement drive against spurious and substandard anticancer drugs, Delhi government inspected 25 firms and collected 55 samples across the city, officials said on Monday. Directed…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    35 drugs manufactured in Telangana fail CDSCO quality checks

    35 drugs manufactured in Telangana fail CDSCO quality checks

    Delhi govt inspects 25 firms, collects 55 samples in crackdown on spurious anticancer drugs

    Delhi govt inspects 25 firms, collects 55 samples in crackdown on spurious anticancer drugs

    ‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly Head

    ‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly Head

    ‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly Head

    ‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly Head

    Jharkhand HC orders FIRover children being given HIV-infected blood during transfusions

    Jharkhand HC orders FIRover children being given HIV-infected blood during transfusions

    Narco Syndicate indulged in supply of Contraband NRX medicines dismantled, arrested two key operatives

    Narco Syndicate indulged in supply of Contraband NRX medicines dismantled, arrested two key operatives