Ranbaxy to pay FDA to end impasse on manufacturing ban

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Ranbaxy to pay FDA to end impasse on manufacturing ban

INICIO/Noticias Farmacéuticas | Posted 17/09/2010 0 Post your comment

Daiichi Sankyo hopes that its interventions may lead to a lift of the FDA’s import ban on 30 products from Ranbaxy, its Indian generic drugs arm.

Press reports indicate that Ranbaxy recently submitted an internal report, compiled in cooperation with a third party, to US regulators at the authorities' request. It was also indicated that Ranbaxy may offer to pay a one-time penalty to settle with the regulator and reset their relationship.

Reports also indicate that an FDA inspection of the company's plants at Dewas and Paonta Sahib, where the troubles began, would follow before matters are resolved.

The ban has been in force since 2008 when GMP violations were not corrected to the satisfaction of the FDA at the two Indian facilities. Then in early 2009, the FDA halted review of drug applications for drugs manufactured at the Paonta Sahib plant, alleging Ranbaxy had falsified data.

This latest development sees a light at the end of the tunnel for the troubled manufacturing sites. Let’s hope that Ranbaxy can get its act together and convince FDA inspectors of its renewed compliance with the regulator’s requirements.

References

Business Standard. Daiichi Sankyo sees progress on Ranbaxy US ban. 3 September 2010.

FDA News Release. FDA Takes New Regulatory Action against Ranbaxy's Paonta Sahib Plant in India. Agency halts review of drug applications from plant due to evidence of falsified data; invokes Application Integrity Policy. 25 February 2009.

FDA News Release. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd. and an Import Alert for Drugs from Two Ranbaxy Plants in India. Actions affect over 30 different generic drugs; cites serious manufacturing deficiencies. 16 September 2008.