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FDA to Pull 31 Apotex ANDAs Due to Manufacturing Concerns

09th July 2019

The US FDA announced that they are withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after they found the manufacturing deficiencies at two of the company’s plants.

The FDA initiated this action after Apotex’s initial request for withdrawal due to the manufacturing issues at two Apotex facilities. Some of the generics listed in the list are Valsartan, losartan, azithromycin and Viagra.

Two facilities involved were India-based Apotex Research Private Ltd. And Apotex Pharmachem India Private Ltd. The later one received a warning letter from the FDA last august due to issues with quality unit. Since April 2018, they were on import alert as well. The site also received a warning letter in January 2015.

The FDA inspectors also found out that the QC microbiologist used to overwrite the testing dates for growth promotion testing to show that testing was done previously.

In June 2014, Apotex Pharmachem India Pvt. Ltd. also received the warning letter; but it was closed in December 2016.

\ In 2015, the Health Canada also offered reservations for two of the Apotex sites; but the court ruled out the order.

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