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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.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
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.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
