Ranbaxy Laboratories announced that it had made provision to pay $500 million in connection with a civil and criminal investigation by the Department of Justice relating to violations of the current Good Manufacturing Practices and falsification of records allowing the company to produce and sell medications that failed to meet FDA standards.  The drugs were then paid for by the President’s Emergency Plan for AIDS Relief program and distributed to foreign countries.  Subsequently, the FDA issued warning letters and banned over 30 medications produced by Ranbaxy plants in India.

Under the settlement, Ranbaxy entered into a Consent Decree with the FDA to improve its data integrity policies and procedures and comply with the cGMPs.

While allegations were pending, Ranbaxy was purchased by Japanese drugmaker Daiichi Sankyo for $4.6 billion.  Daiichi cut the pay of executives and directors and substantially reduced its profit forecast in anticipation of the $500 million settlement.

Read the entire article, “Ranbaxy Pays $500M For Manufacturing Problems”
“Ranbaxy Announces Consent Decree with U.S. Food and Drug Administration”