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Ranbaxy Suspends Shipments, Addresses Quality and Integrity Problems
Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.
Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.
In the meantime the company, based in New Delhi, is establishing a quality and integrity committee to “provide oversight on the company’s manufacturing and quality operations, systems, organization and integrity”, The Times (UK) reports today.
Ranbaxy’s Toansa facility was the last of the company’s plants permitted to export to the U.S., but a recent FDA inspection found it unhygienic and badly maintained.
The ban on imports from Toansa was the latest in a long line of troubles for the company. Last year the FDA imposed a similar ban on products from its Mohali plant,and the Department of Justice fined the drug maker $500m for distributing adulterated medicines in the U.S. between 2004 and 2007.
Beyond the Birthrate: The Societal Costs of Maternal Mortality
September 6th 2024Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.
Efsitora Demonstrates Non-Inferiority vs. Insulin Glargine, Degludec for Type 2 Diabetes
September 5th 2024Results from the QWINT-1 and QWINT-3 trials found that insulin-naïve patients achieved similar reductions in A1C levels using once-weekly efsitora compared to daily insulin glargine and degludec.
