Compounders Beware: API from China May Be Contaminated, FDA

From yesterday’s Regulatory Affairs Professionals News:

"The US Food and Drug Administration (FDA) late Wednesday released a warning for drug compounders that certain lots of the active pharmaceutical ingredient (API) baclofen, manufactured by China’s Taizhou Xinyou Pharmaceutical & Chemical Co., may be at risk for contamination…

“According to the company’s website, Taizhou also produces more than 10 other APIs, including the baldness treatment finasteride…”

The full story here:

raps.org/Regulatory-Focus/Ne … -FDA-Says/