MHRA, TGA Give Clean Review To Ranbaxy’s Paonta Sahib Plant, But U.S. FDA Holds The Key
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - Even as U.S. FDA tightened its scrutiny of Ranbaxy's manufacturing plant at Paonta Sahib in India on alleged charges of falsification of data, two of the world's largest drug regulators - UK's Medicines and Healthcare Products Regulatory Agency and Australia's Therapeutic Goods Administration gave the plant a clean review
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U.S. FDA Nails Ranbaxy On Charges Of Falsifying Data; Halts All Application Reviews From Paonta Sahib Plant
MUMBAI - India's largest drug maker Ranbaxy received a body blow after the U.S. Food and Drug Administration initiated a new regulatory action against the company's Paonta Sahib-based manufacturing plant in India. The drug regulator halted review of drug applications from the manufacturing plant due to evidence of falsified data and invoked the Application Integrity Policy
PharmAsia News Business Bulletin
A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).
PharmAsia News Business Bulletin
A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).