Ranbaxy has introduced generic Lipitor in the US after partnering with Teva and gaining FDA approval for manufacture at its US plant.
Pfizer agreed to allow Ranbaxy to sell Lipitor (atorvastatin) in the US from November 30 but quality problems threatened to scupper the launch. Yesterday the US Food and Drug Administration (FDA) finally gave Ranbaxy approval to manufacture Lipitor at its New Jersey subsidiary Ohm Laboratories.
In 2009 the FDA sent a warning letter to Ohm Laboratories after finding GMP (good manufacturing practice) violations. A year earlier the FDA banned Ranbaxy from selling 30 drugs in the US after it was found guilty of GMP failings at two Indian plants.
Last week India’s Economic Times reported that Ranbaxy was close to reaching a $400m (€300m) agreement with the FDA as part of a settlement package. Neither Ranbaxy nor the FDA referred to a payment in their press releases.
Ranbaxy has partnered with Teva on the launch. During the 180-day first-to-file exclusivity period a portion of profits from Ranbaxy’s sales of Lipitor will be paid to Teva. Watson is also selling Lipitor during the exclusivity period.