The mystery of the glass particles in Ranbaxy’s generic version of Lipitor (Atorvastatin) that led to a major drug recall in the US two weeks back could have its roots in a splintered glass lining at a reactor of its Toansa facility in Punjab, where a part of its active pharma ingredient (raw material) of the drug is made.
This piece of information was shared by Venkat Krishnan, who heads Ranbaxy’s Americas business with an US-based newspaper. The company has stopped the production of generic Lipitor as a precautionary move, Krishnan said, till it gets to the root of the cause and corrects it.
Ranbaxy manufactures a large part of API for this drug at Toansa, while it makes formulations at the US and its Mohali facility in India. Company officials here couldn’t shed more light on the situation
Workers at the US plant discovered foreign particles in late September during routine quality checks of the active ingredient before it is used in manufacturing, Krishnan told the paper.
In October, an independent laboratory identified the particles as glass. Around two weeks back, Ranbaxy said it is recalling its generic version of cholesterol-lowering drug Lipitor from the US market, which would cause temporary disruption in the supply. The company did so without specifying the reason for the recall and without naming the facility where the recalled drug was manufactured.
The company had said that it would take about two weeks to complete the investigation, after which it would resume the supplies to US market.
In September 2008, the US FDA banned over 30 medicines manufactured by the drug maker at its select Indian facilities —Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh.
Four months later, the noose around the company tightened further as the US drug regulator invoked the ‘application integrity policy’, which meant it also decided not to grant any new drug approvals from Paonta Sahib. Since then, the firm has pursued discussions with US agencies, which culminated in the consent decree three years later in December 2011.