FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Regulatory Affairs / Inspections and Audits

FDA Adds Indian API Maker to Import Alert List

Oct. 22, 2015
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The FDA last week placed another Indian active pharmaceutical ingredient maker on its import alert list, adding one of Megafine Pharma sites to 46 other India-based finished drug and API sites whose products are banned from entering the U.S.

Since September 2009, 30 companies’ sites have been placed on import alert, creating a major black eye for India’s pharma industry and its reputation as a global supplier of generic drugs.

Megafine’s Nashik, Maharashtra, India, site produces 24 APIs for the U.S. market, including ambrisentan for hypertension, the anticoagulant apixaban, vildagliptin for diabetes and drugs for Alzheimer’s disease, depression, schizophrenia, multiple sclerosis and overactive bladder.

The FDA did not specify what issues resulted in the import alert. Megafine’s site in Vape, India, is not listed on the import alert list.

The company also exports its APIs to the EU, Canada, Mexico, Australia, Brazil and South America, according to its website.

This is the fifth Indian drugmaker placed on import alert since July. Last month, the FDA added Mumbai, India-based Polydrug Laboratories to the list, citing GMP violations at its Ambernath, India, plant. In August, Akorn India’s Himachal Pradesh site and Sri Krishna Pharmaceuticals’ Andhra Pradesh plant were listed. In July, Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, plant was banned. — Kellen Owings