USFDA Inspects Ranbaxy’s New Facility in Mohali

27 Jun 2011 Evaluate

American drug authorities have started inspecting Ranbaxy Laboratories’ new drug manufacturing facility in Mohali in Punjab, which, if it goes well, could help the country’s largest drug maker resume supplies to the US nearly three years after they were halted from its two main plants. The inspection began a little over a week ago.

In September 2008, the US Food and Drugs Administration (FDA) banned import of 30 medicines and halted approvals for new drugs made at Ranbaxy’s plants at Dewas and Paonta Sahib, saying the Gurgaon-based drug maker fabricated data to get marketing approval to sell its medicines. For about two years now, Ranbaxy has been in discussions with the authorities in the US, the world’s largest market for medicines, for a comprehensive settlement.

Resumption of supplies to the US is crucial for the company as the American market accounts for about a quarter of its $1.9-billion annual sales. Its most awaited launch, cholesterol reducer atorvastatin, a generic version of Pfizer owned world’s best-selling drug Lipitor, is scheduled in November. Ranbaxy’s management has previously filed multiple marketing applications for atorvastatin from its FDA-approved plants.

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