Compounders Beware: API from China May Be Contaminated, FDA Says

Regulatory NewsRegulatory News | 10 December 2015 |  By 

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.

“FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in injectable drugs,” the agency warned.

The API, which is often used as a muscle relaxant, could pose serious safety risks for patients who receive injectables with the API, particularly when administered to the spinal column.

“There is also a potential risk that the baclofen API may be contaminated by endotoxin or microorganisms.  FDA is continuing to investigate this incident,” the agency said.

According to the company’s website, Taizhou also produces more than 10 other APIs, including the baldness treatment finasteride and its intermediates, sulbactam, which is part of an antibiotic, the antibiotic cefodizime acid, and 4-amino-3-phenylbutyric acid hydrochloride, and 4-aminobutyric acid.

The alert on Taizhou comes as FDA recently banned imports from three other China and Hong Kong-based API, pharmaceutical and cosmetics companies.

Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination


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