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Culture Clash: U.S. FDA Tries to Re-educate Indian Firms on Processes And Accurate Reporting

This article was originally published in PharmAsia News

Executive Summary

FDA has essentially shut down Ranbaxy’s three-year-old facility at Mohali as a source for products for the US market. But Ranbaxy is not alone among Indian firms in its quality product disputes with the agency. There is a significant uptick in activity by FDA in the region in what appears to be a period of intense culturization for the Indian firms into the ways FDA enforces cGMPs and handles on-site inspections.

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