FDA Withdraws Approval of 31 ANDAs from Apotex

cGMP deficiencies prompted FDA to withdraw approval for 31 Apotex ANDAs

In July 2019, FDA published a note in the US Federal Register that it is withdrawing its prior approval of 31 abbreviated new drug applications (ANDAs) from Apotex, due to cGMP issues at two of the company’s facilities. The Agency had cited some of these problems in August 2018. Included are applications for azithromycin, losartan, irbesartan, and montelukast sodium.

The two facilities involved are Apotex Research Private Ltd. and Apotex Pharmachem Private Ltd., both based in India. Apotex Research Private has been on import alert since April 2018.

In the past, regulators had cited underperformance in a number of areas, not only such broad issues as inadequate quality systems and insufficient management oversight and control, but also problems with data integrity and failure to take sufficient corrective and preventive actions in response to quality problems.

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