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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.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
