Recent Event Highlights: Ranbaxy made “untrue” 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
Ranbaxy’s problems with the US FDA were ratcheted up a notch yesterday when the agency halted its review of products made at the firm’s plant in Paonta Sahib, India after uncovering “untrue statements” in ANDA’s and NDA filings.
http://www.in-pharmatechnologist.com/Processing-QC/Ranbaxy-made-untrue-statement-in-filings-says-FDA
Daiichi Sankyo has completed its $4.5bn (€3.5bn) purchase of Indian generics giant Ranbaxy Laboratories, quashing speculation that the Japanese firm would withdraw as a result of Ranbaxy’s ongoing problems in North America.
http://www.in-pharmatechnologist.com/Industry-Drivers/Daiichi-buys-Ranbaxy-for-4.5bn
Ranbaxy’s antiretrovirals zidovudine, lamivudine, and nevirapine have been removed from PEPFAR’s list of approved products until ongoing GMP problems at two of the firm’s Indian manufacturing plants are resolved.
http://www.in-pharmatechnologist.com/Industry-Drivers/PEPFAR-drops-Ranbaxy-from-recommended-list
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.
http://www.in-pharmatechnologist.com/Industry-Drivers/Health-Canada-adds-to-Ranbaxy-s-woes
The FDA has issued generics giant Ranbaxy Laboratories with two warning letters, detailing “extensive deviations from US cGMP requirements” at the firm’s manufacturing plants in Dewas and Paonta Sahib, India.
http://www.in-pharmatechnologist.com/Processing-QC/FDA-blocks-imports-from-two-Ranbaxy-plants
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).
http://www.in-pharmatechnologist.com/Industry-Drivers/Pharma-manufacturing-People-on-the-move3
Ranbaxy’s CEO has confidently asserted that the US Food and Drug Administration’s (FDA) court action will be dropped in the near future and fired another warning shot at the “negative elements” he believes were behind the controversy.
http://www.in-pharmatechnologist.com/Industry-Drivers/Ranbaxy-expects-probe-to-be-dropped-soon
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.
http://www.in-pharmatechnologist.com/Industry-Drivers/Ranbaxy-claims-big-pharma-company-behind-falsification-accusations
The US offices of Indian pharmaceutical company Ranbaxy were subjected to a search by federal officials the company reported last week.
http://www.in-pharmatechnologist.com/Materials-Formulation/Ranbaxy-raided-by-US-officials
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