Another Import Ban for Polydrug Laboratories
USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for company’s Ambernath industrial area manufacturing plant in Mumbai, India. Import ban was issued due to problems with good manufacturing practices for human and animal drugs. Canada and Europe has already banned products from the same site earlier this year.
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 FDA does not provide specifics in its import alerts. Comapny will remain in red list until FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA official. Polydrug laboratories 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 the FDA website the ban on Polydrug makes the total number of Indian drug manufacturing facilities that currently barred from exporting to the United States to 44 from 2011 to till now.