Will Ranbaxy Pay A Big Fine To End FDA Problems?

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ranbaxy-fineTwo years after the FDA came down hard on Ranbaxy Laboratories, the generic drugmaker is reportedly offering to make a sweeping, one-time penalty payment in hopes of convincing the agency to allow shipments of various drugs to the US to resume. Such a payment, which is usually tied to a consent decree, may constitute as much as 20 percent of revenue over the past three years. The news was reported on MoneyControl and Ranbaxy officials refused to comment, but did not deny the report (watch the video here). We await a reply from the FDA.

You may recall that, two years ago, federal prosecutors cited the Indian drugmaker for allegedly falsifying records that resulted in the production and sale of meds failing to meet FDA standards. The allegations included fabricating bioequivalence and stability data to support AIDS drugs to be paid for by the President’s Emergency Plan for AIDS Relief program (PEPFAR) and distributed to foreign countries (back story).

Then, the FDA issued warnings letters and banned more than 30 meds made at two plants in Dewas and Paonta Sahib in India (see here). Since then, Daiichi Sankyo, which agreed to pay $4.6 billion for Ranbaxy despite these problems, has attempted to overhaul management, but suffered yet another setback when Atul Sobti resigned as Ranbaxy ceo over strategic disagreements (look here).

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