FDA Issues Import Ban for Indian Drug Manufacturer

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-10-07-2015, Volume 11, Issue 10

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

FDA has issued an import ban on Sept. 11, 2015 for products manufactured by Polydrug Laboratories at the company’s Ambernath Industrial Area manufacturing plant in Mumbai, India, due to problems with good manufacturing practices for human and animal drugs.

The company manufactures anti-hypertensive, anti-fungal, anti-microbial, and muscle relaxant drugs, and distributes products in Mexico, China, Korea, Russia,Taiwan, Singapore, and Ukraine, according to information posted on the Polydrug Laboratories website.

Reuters reports that Canada and Europe banned products from the same site earlier this year.


Source: FDA Import Alert