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FDA Warning Letters Hit Three Repackers For Failing To Identify Original API Makers

 
• By Joanne S. Eglovitch

The US FDA’s concerns about the transparency of the pharmaceutical supply chain surfaced in three recent drug GMP warning letters to drug repackers of active pharmaceutical ingredients who failed to disclose the names of the API manufacturers to their customers. Janet Woodcock, director of the agency's drug center, called such lack of transparency a "real threat" to public health that must be addressed quickly.  

Warning Rubber Stamp

The US Food and Drug Administration recently issued three drug GMP warning letters to drug repackers of active pharmaceutical ingredients for omitting the name of the original manufacturers of the active pharmaceutical ingredients to customers, a common practice in the API sector that the agency wants to stop.

The three repackers were all in the US: B&B Pharmaceuticals in Englewood, CO; Asclemed USA, also known as Enovachem, in...

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