Ranbaxy's Mohali plant, which received an import alert from the US Food and Drug Authority (USFDA), has now been added to the consent decree signed by the company in January 2012.
In yet another blow to Ranbaxy , the US Food and Drug Authority (USFDA) has added Ranbaxy's Mohali plant to the Consent Decree, which was signed by the drug major in January 2012.
The Consent Decree was for regulatory uphaul at its Paonta Sahib and Dewas plants. The Mohali plant had received an import alert from the USFDA earlier on Monday.
The action comes on the back of failure by Ranbaxy to rectify violations almost a year after it was revealed in the audit and will have wider implications, reports CNBC-TV18’s Archana Shukla.
However, the US FDA statement says that the Mohali facility will be subject to the same terms of the consent decree and of permanent injunction entered against Ranbaxy in January 2012.
Also, none of the new drug filings made from Mohali plant would be considered for approval by USFDA until the consent decree, which now covers all three Indian plants, is completed.
It was anticipated that post the regulatory issues at Paonta Sahib and Dewas, these drug filings were transferred to Mohali. Now, concerns would be raised also for Ranbaxy’s ability to monetize its exclusive marketing opportunity for Astrazeneca’s heartburn drug Nexium, which goes off-patent in May 2014.
However, the USFDA statement through much light on the problems that has been plaguing Ranbaxy’s Mohali plant.
Ranbaxy Labs stock price
On July 25, 2014, at 14:29 hrs Ranbaxy Laboratories was quoting at Rs 575.55, up Rs 14.25, or 2.54 percent. The 52-week high of the share was Rs 578.65 and the 52-week low was Rs 253.95.
The latest book value of the company is Rs 25.87 per share. At current value, the price-to-book value of the company was 22.25.
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