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FDA warning: Ranbaxy issues clarification

FDA warning: Ranbaxy issues clarification
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First Published: Wed, Sep 17 2008. 11 12 AM IST
Updated: Wed, Sep 17 2008. 11 12 AM IST
New Delhi: In response to a US Food and Drug Administration (US FDA) issuing warning letters and announcing an import alert for drugs issued to Ranbaxy Laboratories, the company has said that it is very disappointed in the action FDA has taken.
“Ranbaxy is very disappointed in the action 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,” the company said in a release.
“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,” the release states.
“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,” it added.
According to the FDA announcement, the warning letters and import alert does not apply to the Indian pharma company’s other facilities including its three manufacturing facilities in the US, Ohm’s Laboratories facilities in New Brunswick, North Brunswick, and Gloversville from which Ranbaxy delivers around 59 drug products to the US healthcare system.
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First Published: Wed, Sep 17 2008. 11 12 AM IST
More Topics: Ranbaxy | FDA | Pharma | Warning Letters | API |