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Apotex Withdraws 31 ANDAs After Failing To Ensure Data Integrity At Two Indian Manufacturing Plants

 
• By Bowman Cox

Persistent data integrity and quality unit failures at two Apotex plants in Bangalore, India, led to wholesale US market withdrawals by the Canadian generic drug manufacturer.

withdrawn-stamp
data lapses eventually undermined approvals

It appears that the US Food and Drug Administration’s growing frustration with a Canadian drug maker’s continuing failure to establish an effective quality system and ensure data integrity at two facilities in India has led to the firm’s withdrawal of 31 generic drug approvals listed in a Federal Register notice slated for publication on 10 July.

Apotex Inc.’s decision to withdraw the abbreviated new drug applications is an unprecedented outcome of the data integrity crisis...

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