FDA Prohibits Facility from Producing and Distributing Drug Ingredients for US Market
January 29, 2014 5:20 PM
A Food and Drug Administration (FDA) decree has prohibited Ranbaxy Laboratories, Ltd, from manufacturing and distributing active pharmaceutical ingredients (APIs) from the company’s facility in Toansa, India, for use in FDA-regulated drug products. An inspection of the facility on January 11, 2014, identified significant current good manufacturing practice violations, including retesting of raw materials, intermediate drug products, and finished APIs in order to produce acceptable findings after items failed analytical testing and specifications. According to an FDA press release, the facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.
Under the decree, FDA has issued an order prohibiting Ranbaxy from:
◾Distributing drugs manufactured using APIs from Toansa in the United States, including drugs made by Ranbaxy’s Ohm laboratories in New Jersey;
◾Manufacturing APIs at its Toansa facility for FDA-regulated drug products;
◾Exporting APIs from Toansa to the US for any purpose; and
◾Providing APIs from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.
If FDA determines that a medically necessary drug is in shortage or at risk of shortage as a result of this action, the agency may modify this order in order to preserve patient access to the drugs manufactured under controls that are sufficient to assure quality, safety, and effectiveness, indicates the press release.
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