FDA pulls 31 ANDAs from troubled generics maker

Jul 10, 2019

The challenges are mounting for Canadian generics drugmaker Apotex. 

In 2017, the company’s CEO and his wife were found murdered in their Toronto mansion. With the crime still unsolved, reports surfaced last year that Apotex was looking to sell its business for around $3 billion. 

Now this week, the FDA announced that it is withdrawing 31 abbreviated new drug applications (ANDAs) from the company after manufacturing deficiencies were identified at two of its India-based plants. The ANDAs reportedly include Viagra generics, azithromycin, and valsartan and losartan — two of the blood pressure meds involved in a global recall due to toxin contamination.  

The FDA first issued a warning letter to Apotex in August after a 2017 investigation found numerous out-of-spec lab results and manufacturing deviations. Overall, the company received three warning letters in four years and was also called out on data integrity issues. 

Apotex has owned operations in 45 countries and last year, sold off plants and infrastructure in five EU countries to an Indian drugmaker, Aurobindo Pharma, for $83 million. 

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