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Ranbaxy disappointed with US FDA move
 
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September 17, 2008 12:33 IST

Decrying the American health regulator's move to ban import of drugs from its two plants, pharma major Ranbaxy [Get Quote] on Wednesday said it had responded to every issue raised by them in the last two years.

"Ranbaxy is very disappointed in the action Food and Drug Administration (FDA) has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made," Ranbaxy said in response to US FDA's warning letters and import alert.

The US FDA has issued two warning letters to Ranbaxy Laboratories and an import alert for generic drugs produced by Ranbaxy's manufacturing facilities in Dewas (Madhya Pradesh) and Paonta Sahib, including the Batamandi unit, in Uttar Pradesh.

Shares of Ranbaxy plunged by as much as 10 per cent to witness an intra-day low of Rs 363.10 on the Bombay Stock Exchange on Wednesday. The scrip was later trading at Rs 375, down 7.61 per cent and over 479,000 shares exchanged hands on the BSE.

According to the FDA announcement, the warning letters and import alert would not be applied to Ranbaxy's other facilities including its three units in the US, Ohms Laboratories facilities in New Brunswick, NJ, North Brunswick, NJ, and Gloversville, NY, the company said.

Ranbaxy delivers about 59 drugs from the above mentioned facilities to the US. The drugs include Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended tablets, Lisinopril and Zolpidem.

"We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved," Ranbaxy further added.

"Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues," Ranbaxy said.


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