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27 Nov 2014

180 day exclusivity could be granted to more than one applicant. Is it correct?

Observation is not correct. Generally 180 Days exclusivity is given only to the one company by USFDA. But innovator campnay holds the right to nominate to have one generic manufacturer to manufacture the generic version. In case of patent expiry of ATORVASTATIN Pfizer has given the power to Watson to manufacture and launch and ​reg agency given 180 days exclusivity to Ranbaxy.

ANDA FILING STRATEGIC MANAGEMENT COURSE BY ROYED TRAINING

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