The FDA has nailed another Teva manufacturing facility with a warning letter, this time for an API facility in China.

The FDA’s decision to ban the products of a Chinese API maker has left the World Health Organization in the lurch trying to find another company to supply the…

Another Mylan plant in India has been issued a warning letter.

The FDA has nailed India's Indoco with a warning letter for a sterile and solid dose plant in Goa because of its concerns over an injected drug.

A New Jersey man wanted for smuggling unapproved erectile dysfunction drugs into the U.S. has been deported back to the U.S. after he was located in China by…

All of Wockhardt's U.S. targeted  manufacturing facilities are under some kind of FDA oversight, but the Indian generics maker got a new product approved…

An Indian drugmaker whose Mumbai plant got nailed by an FDA warning letter several years ago is again under the gun for making some of the same mistakes at a…

China's Food and Drug Administration proposed changes to its foreign drug approval rules in a bid to speed new, innovative meds to market.

Regulatory