Apotex goes from FDA poster boy to naughty corner

A week ago, the US Food and Drug Administration (FDA)  held up Apotex’s submission for potassium chloride as the first application to market a copycat drug that merited being granted the regulator’s new Competitive Generic Therapy designation.

Now news has broken that the privately-held Canadian generic drugmaker remains in the bad books of the FDA in another area, having received a latest warning letter notifying the company of its violations of current good manufacturing practice (CGMP) regulations.

The letter accuses the firm of failing to thoroughly investigate unexplained discrepancies or failures of batches to meet specifications and of failing to establish valid in-process specifications at its site in Bangalore, India.