Recent Event Highlights: Ranbaxy made â€śuntrueâ€ť statement in filings says FDA, FDA blocks imports from two Ranbaxy plants, Ranbaxy hires Rudi Giuliani to address FDA issues, and 6 more...
Created by DNMPharma2 on 27/02/2009
Last updated: 11/03/10 at 00:05
Ranbaxyâ€™s problems with the US FDA were ratcheted up a notch yesterday when the agency halted its review of products made at the firmâ€™s plant in Paonta Sahib, India after uncovering â€śuntrue statementsâ€ť in ANDAâ€™s and NDA filings.
Daiichi Sankyo has completed its $4.5bn (â‚¬3.5bn) purchase of Indian generics giant Ranbaxy Laboratories, quashing speculation that the Japanese firm would withdraw as a result of Ranbaxyâ€™s ongoing problems in North America.
Ranbaxyâ€™s antiretrovirals zidovudine, lamivudine, and nevirapine have been removed from PEPFARâ€™s list of approved products until ongoing GMP problems at two of the firmâ€™s Indian manufacturing plants are resolved.
A domino effect appears to have been started by the FDA blocking Ranbaxy imports, with other regulatory bodies paying close attention to the generics giant.
The FDA has issued generics giant Ranbaxy Laboratories with two warning letters, detailing â€śextensive deviations from US cGMP requirementsâ€ť at the firmâ€™s manufacturing plants in Dewas and Paonta Sahib, India.
Ranbaxy Laboratories has hired Rudy Giuliani, the former mayor of New York, to assist it in overcoming its recent issues with the US Food and Drug Administration (FDA).
Ranbaxyâ€™s CEO has confidently asserted that the US Food and Drug Administrationâ€™s (FDA) court action will be dropped in the near future and fired another warning shot at the â€śnegative elementsâ€ť he believes were behind the controversy.
Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the company's share price by initiating the accusations that the generics manufacturer falsified data to achieve compliance.
The US offices of Indian pharmaceutical company Ranbaxy were subjected to a search by federal officials the company reported last week.