Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs

Regulatory NewsRegulatory News | 09 July 2019 |  By 

The US Food and Drug Administration (FDA) on Tuesday said it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after manufacturing deficiencies were found at two of the company’s plants.

The FDA action follows Apotex’s initial request to withdraw the ANDAs in January 2018. FDA said it became aware of concerns involving material manufactured at the two Apotex facilities, at least one of which was named in each of the pulled ANDAs. Valsartan, losartan, azithromycin and Viagra generics are among the ANDAs listed.

The two facilities involved, according to FDA, were India-based Apotex Research Private Ltd. and Apotex Pharmachem India Private Ltd.

Last August, FDA issued a warning letter to Apotex Research Private, raising concerns with the firm’s quality unit. The site has been on import alert since April 2018.

“Your investigations into out-of-specification (OOS) laboratory results and manufacturing deviations are insufficient and do not include scientifically-supported conclusions,” FDA said in its warning letter, offering multiple examples. The site also received a warning letter from FDA in January 2015.

And in a previous Form 483, FDA said its inspectors found that a QC microbiologist “was observed overwriting the dates for previously read (awaiting disposal) growth promotion plates using a black marker in order to make it appear that the growth promotion testing had been performed previously.”

The other site, Apotex Pharmachem India Pvt., received a warning letter in June 2014, but that letter was closed out in December 2016.

Health Canada in 2015 also offered its reservations on the two Apotex sites, even though a federal court ruled the regulator could not limit imports from the two facilities.

Federal Register


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Tags: ANDAs, Apotex, FDA, sartan

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