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HindustanTimes Wed,01 Oct 2014

US bans supply of drugs from Ranbaxy's Nawanshahr plant

Press Trust of India, PTI  Washington/New Delhi , January 24, 2014
First Published: 17:03 IST(24/1/2014) | Last Updated: 13:24 IST(25/1/2014)

In yet another setback for Ranbaxy, the US health regulator has banned the supply of products from the Indian pharmaceutical giant's fourth plant, halting the shipment of the company's drugs to the US.

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Citing manufacturing norm violations, the US Food and Drug Administration (FDA) prohibited Ranbaxy Laboratories from distributing drugs produced at the company's unit at Toansa village in Punjab's Nawanshahr district, besides medicines made by the company's Ohm Laboratories facility in New Jersey (US).

In an order on Thursday, the US FDA also prohibited Ranbaxy from providing active pharmaceutical ingredients from Toansa to other companies, including other Ranbaxy facilities that make products for American consumers. "We are taking swift action to prevent substandard quality products from reaching US consumers," said Carol Bennett, acting director (compliance) in the FDA's Centre for Drug Evaluation and Research.

The FDA said it exercised its authority under a provision in a January 2012 consent decree, which permits the agency to extend those terms to any Ranbaxy-owned or -operated facility if an FDA inspection finds it in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including current good manufacturing practice requirements.

Shares plunge

Ranbaxy shares plunged by 19.54% to Rs. 335.65 at the close on the Bombay Stock Exchange (BSE). Its other key facilities at Paonta Sahib (Himachal Pradesh), and Dewas (Madhya Pradesh), are already under a US import alert since 2008. Last year, its other key facility at SAS Nagar also came under FDA import alert.

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