Ranbaxy Laboratories controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2016
Daiichi Sankyo arbitration award
The Singapore International Court of Arbitration ordered former Ranbaxy shareholders to pay Daiichi Sankyo $525 million after concluding that the severity of regulatory scrutiny had been intentionally misrepresented.
2014
FDA action against Toansa facility
The FDA prohibited the manufacture and distribution of active pharmaceutical ingredients from Toansa for FDA-regulated products after finding that failed materials and test results had been repeatedly retested without proper reporting or investigation.
2013
US felony convictions and $500 million settlement
Ranbaxy pleaded guilty to three felony violations of the Federal Food, Drug, and Cosmetic Act and four felony counts of knowingly making false statements to the FDA. The case involved adulterated medicines and misrepresented generic-drug data.
2013
Mohali manufacturing deficiencies
Reports described serious sanitation and manufacturing deficiencies at the Mohali facility, after which the FDA prohibited the site from manufacturing FDA-regulated drugs until compliance requirements were met.
2013
U.S. manufacturing and data-integrity case
The U.S. Department of Justice announced that Ranbaxy pleaded guilty to felony charges and agreed to a major settlement over the manufacture and distribution of adulterated drugs and false or misleading statements to the U.S. Food and Drug Administration. The case concerned quality systems, manufacturing conditions, testing, and regulatory data.
2012
Product recalls involving pantoprazole and atorvastatin
Pantoprazole batches were recalled in the Netherlands because of impurities. Ranbaxy also stopped production and recalled atorvastatin lots after glass particles were found in bottles; a labeling and dosage error later led to a US recall.
2009
FDA suspends review of Ranbaxy applications
The FDA halted reviews of Ranbaxy drug applications after investigators found evidence that data associated with the Paonta Sahib facility had been falsified and that another nearby facility had been presented as the source of products.
2004
Whistleblower allegations concerning fraudulent testing data
Rajinder Kumar resigned after raising concerns about medicines approved using allegedly fraudulent testing. Dinesh Thakur later became a whistleblower after compiling information about the alleged data manipulation.
2003
Audit identifies patient-safety and record-keeping weaknesses
An audit by Lachman Consultant Services reported that Ranbaxy's patient-safety function did not adequately investigate or report adverse-effect and ineffectiveness complaints and also identified poor manufacturing records.