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HindustanTimes Thu,18 Dec 2014

Ranbaxy withdraws 27 drugs from US market

PTI  New Delhi, August 22, 2012
First Published: 19:27 IST(22/8/2012) | Last Updated: 19:36 IST(22/8/2012)

Drug major Ranbaxy Laboratories on Wednesday said it has withdrawn 27 drugs from the US market due to commercial reasons.

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"The company has determined that certain products with negligible commercial impact should be withdrawn to enable the organisation to focus resources on other applications that are of greater importance and value to the US business and healthcare system," Ranbaxy said in a filing to the BSE.

The abbreviated new drug approvals (ANDAs) do not pertain to current business and will have a negligible impact on the company's business in the US, it added.

However, as per information available on the US Government Printing Office (GPO), which provides publishing and dissemination services for the official and authentic government publications to Congress and federal agencies, Ranbaxy requested withdrawal of approval under a consent decree.

"Ranbaxy requested withdrawal of approval under a consent decree of permanent injunction filed on January 26, 2012. The decree specifies that Ranbaxy must never submit another application to FDA for these withdrawn drug products and must never transfer these ANDAs to a third party", GPO said in its website.

It added: "Therefore...under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective September 21, 2012".

Ranbaxy had filed a consent decree with a US court in January this year as part of its settlement with the American authorities regarding a ban on certain manufacturing plants operated by the company in India.

In 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi unit in Himachal Pradesh, citing gross violation of approved manufacturing norms.

The list of drugs which the company has withdrawn from the US market includes Ofloxacin and Fluconazole tablets.

Shares of Ranbaxy today closed at Rs. 534.50 on the BSE, up 4.12%  from its previous close.


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