Ranbaxy Woes Continue With 30-plus Product Import Alert
This article was originally published in PharmAsia News
Executive SummaryFDA will lift a portion of its import alert for generic drugs made in two of Ranbaxy's facilities to allow the company to import antiviral ganciclovir to avoid a drug shortage
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The U.S. drug regulatory agency highlighted Ranbaxy’s faulty manufacturing practices, strongly retaliating to its claims in a lawsuit challenging the recent decision to rescind tentative approvals for generic versions of Nexium and Valcyte. Among others, the FDA brought up a few strong points like how it had backed arguments in the past that led to Ranbaxy gaining exclusivity approvals on two drugs.
In the final stage of a drawn-out saga, Ranbaxy will pay $500 million to U.S. federal agencies to settle civil and criminal proceedings related to manufacture and supply of adulterated drugs from two Indian sites.
U.S. FDA Issues Life Ban For 27 Ranbaxy Products, Company Says Move To Have “Negligible Commercial Impact”
A consent decree signed in January specified Ranbaxy must never submit another application for the withdrawn products.