Ranbaxy Consent Decree Includes Unusual Provisions On Exclusivity Relinquishment
The company’s consent decree with FDA contains unusual language governing the relinquishment of marketing exclusivity for up to eight pending ANDAs. Since the products have not been publicly identified, it is unclear whether the provisions are punitive in nature, reflect technical defects with the applications or merely clarify a 2003 statutory requirement governing forfeiture.
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Ranbaxy’s $500 Million GMP Settlement Would Be Second Most Expensive For Rx Manufacturing Violations
Ranbaxy Laboratories said it has signed a consent decree with FDA and set aside $500 million to settle a related Department of Justice investigation involving GMP violations and data integrity issues at its Indian facilities.
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