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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FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.
Ranbaxy is back in the news for GMP violations at its Dewas unit in India. Based on an inspection in June, this time Germany’s drug regulator has raised the red flag, citing deficiencies in design and clean room operations, among others. For its part, Ranbaxy clarified that it had decided to discontinue making injectable cephalosporins well before the joint inspection and that all its other facilities were cleared post the inspection.
Sun Pharma’s Dilip Shanghvi bought out Ranbaxy to push ahead in the fast-evolving global generics industry. In contrast to wide speculation that the Ranbaxy deal was inked over a short time, bankers who spoke divulged a well-planned and studied move that began as early as in 2012 and culminated into the final agreement now.