FDA cites manufacturing concerns at Apotex’s India facilities, withdraws approval of 31 ANDAs

By PharmaCompass

2019-07-11

Impressions: 94 Article

The US Food and Drug Administration (FDA) announced it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Canadian generic major Apotex.

The agency cited manufacturing concerns at two Apotex facilities in India as the reason for the withdrawal as at least one of the facilities had been named in each of the applications. The two facilities — Apotex Private Research Limited and Apotex Pharmachem India Private Limited — have been in compliance trouble for some years now.

In January 2018, Apotex requested withdrawal of the ANDAs and recently waived its opportunity for a hearing.

In April 2018, Apotex Research Private Limited was placed on FDA’s import alert. The action was the result of FDA’s inspection at the finished pharmaceuticals manufacturing site located in Bengaluru (India) from November 6 to 17, 2017. The FDA warning letter revealed that Apotex’s investigations into “out-of-specification (OOS) laboratory results and manufacturing deviations were found to be insufficient and did not include scientifically-supported conclusions”.

FDA had also questioned the authority of the quality unit and said it has cited similar current good manufacturing practices (cGMP) violations and deviations at this and other facilities in Apotex’s network. In the last six years, FDA has taken the following actions in response to cGMP violations and deviations at Apotex facilities:

1. FDA placed Apotex Pharmachem India Private Limited on import alert on April 1, 2014, and issued a warning letter on June 16, 2014, which cited failure to investigate and document OOS results.

2. FDA placed Apotex Research Private Limited on import alert on September 22, 2014, and issued a warning letter on January 30, 2015, which cited failure to follow written procedures applicable to the quality control unit.

Previously, at several regulatory meetings, FDA had communicated to the Apotex senior management the need for appropriate and global quality oversight. The FDA had mentioned that the repeated failures at multiple sites revealed management oversight and control over the manufacture of drugs was inadequate.

It has been over a year since Apotex founder Barry Sherman and his wife Honey were murdered in their Toronto home. In April, a Bloomberg news report had stated that the Canadian drugmaker is exploring a sale.

After the incident, members of the Sherman family have been managing the business while having a financial advisor on its board. Apotex is exploring a partial or full sale of its Canadian operations that could fetch around US$ 3 billion.

This week, the FDA also posted its warning letter to US generic drugmaker Akorn and its Form 483 issued to Dr Reddy’s and Indoco.

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