Ranbaxy Making Generic Lipitor Again in US

Ranbaxy Making Generic Lipitor Again in US

February 22nd, 2013 // 4:24 pm @


Three months after halting production of generic Lipitor due to tiny glass particles found in some lots, the troubled drugmaker says production has resumed. The move, which Ranbaxy hopes will end yet another embarrassing episode, comes after weeks were spent working with the FDA and implementing “multiple corrective and preventive actions,” according to a statement.

As noted previously, the recall came at a delicate time for Ranbaxy, which early last year signed a consent decree for a permanent injunction that prevents the Indian drugmaker from making medicines for the US market until certain facilities meet US standards (read here). The drugmaker set aside $500 million to cover all potential civil and criminal liability, but the final amount of any settlement has not yet been decided.

Just weeks before the consent decree was issued, however, the FDA allowed Ranbaxy to sell generic Lipitor. The blessing was bestowed just as a 180-day exclusivity period was about to begin and culminated weeks of on-again, off-again speculation about whether Ranbaxy would have an opportunity to begin recovering from a raft of manufacturing problems (back story).

Since the recall, which Ranbaxy has described as voluntary, the drugmaker has also been fighting in court with consumers, who want the drugmaker to recall all generic Lipitor that was shipped, citing alleged harm and an inability to obtain refunds. For its part, Ranbaxy has challenged their credibility and maintained that any consumer who suffered harm would have done so by this time (read more here).

The recall was for its 10mg, 20mg and 40mg dosage strengths, packaged in 90′s and 500 count bottles, and only pertained to specific lot numbers, but did not affect the 80mg strength.

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