Ranbaxy Laboratories has resumed manufacturing in the USA of its generic version of Lipitor after solving contamination problems.
In November, the Indian drugmaker recalled some batches of generic Lipitor (atorvastatin) that contained small glass particles less than 1mm in size. That recall, which affected 10mg 20mg and 40mg dosage strengths, was followed by a decision to halt production altogether until a full investigation was completed.
Now Ranbaxy says that it has been working with the US Food and Drug Administration and “identified and implemented multiple corrective and preventative actions” related to the contamination issue. The company added that "as part of the first step in initiating the manufacturing process to resume supplies to the US market, we have commenced the production of the drug substance for our atorvastatin product".
In 2009, an import ban was placed on 30 of Ranbaxy’s generics over manufacturing violations at its Dewas and Paonta Sahib plants in India but that situation was resolves over a year ago. However the company is still operating under a consent decree and its production processes are under considerable scrutiny.