The hits keep coming- Apotex loses 31 drug approvals after FDA cites plants for inadequate controls

fiercepharma | July 10, 2019

The hits keep coming- Apotex loses 31 drug approvals after FDA cites plants for inadequate controls
Its been a troubled few years for Canadian generics maker Apotex after the unsolved murder of founder Barry Sherman and a possible sale in the works. Now, after multiple warnings from the FDA, Apotex faces a future without approvals for a big slice of its portfolio. The FDA yanked 31 of Apotex’s generic drug nods Wednesday after the agency identified manufacturing deficiencies at two of the drugmaker’s India-based plants. The list of drugs that lost their FDA blessing includes the common blood pressure drugs valsartan and losartan, the antibiotic azithromycin and copycat Viagra. The withdrawn approvals follow a warning letter issued in late 2018, Apotex's third in four years, which cited a lack of accuracy and integrity in the site’s data production. The drugs on the list were approved by the FDA between 2007 and 2014. “FDA has previously communicated about the need for appropriate and global quality oversight to Apotex senior management during several regulatory meetings,” the agency said in its warning letter (PDF) in August. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.” Apotex valsartan and losartan products were among those pulled off the market in Australia and Canada amid the global recall of drugs in that class. Potential cancer-causing impurities were found in active ingredients used by multiple drugmakers around the world.

Spotlight

As pharmaceutical companies move increasingly toward changing production methods from batch to continuous processing, there is a need to re-evaluate the types and formulations of the excipients used. Within a continuous process, conventional monofunctional excipients must be added through individual feeders, potentially creating multiple sources of variability. In contrast, a single high-functionality co-processed excipient requires only one feeder, thus enhancing product performance while minimizing variability. 

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Spotlight

As pharmaceutical companies move increasingly toward changing production methods from batch to continuous processing, there is a need to re-evaluate the types and formulations of the excipients used. Within a continuous process, conventional monofunctional excipients must be added through individual feeders, potentially creating multiple sources of variability. In contrast, a single high-functionality co-processed excipient requires only one feeder, thus enhancing product performance while minimizing variability.