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Ranbaxy vs US FDA

Ranbaxy vs US FDA

Drug maker Ranbaxy Laboratories has reached an agreement with the US health regulator to lift a ban on import of drugs from its certain factories in India.
1. September 2008: Quality and manufacturing issues at Ranbaxy's facilities in Dewas and Paonta lead to the US Food and Drug Administration banning 30-odd drugs.

2. July 9, 2011:
Ranbaxy nears a settlement with the US FDA, penalty estimated at $300-400 million.

3. Nov 30, 2011: US FDA gives the first positive cue in three years, approves Ranbaxy's completed dosage plant in Mohali.

4. Dec 8, 2011: Manjeet Bindra is appointed as the data reliability officer in the US to prevent FDA violations.

5. Dec 22, 2011: Ranbaxy decides to pay $500 million upfront as penalty to the US FDA.

Anamika Butalia

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