Ranbaxy begins US exports of generic Lipitor from Mohali

Ranbaxy Laboratories Limited today said that it had commenced exports of atorvastatin tablets to the US market, from its Mohali facility.

The first consignment of atorvastatin, which is a generic version of Pfizer's lipitor, were shipped to the US in March 2012, it added.

Daiichi Sankyo-owned Ranbaxy, India's biggest drugmaker by sales, has so far been making the drug at its US subsidiary, Ohm Laboratories Inc, USA.

Arun Sawhney, CEO and managing director, Ranbaxy, said, "The resumption of supplies from India into the US market, is a significant milestone for Ranbaxy.
He added, "... our Mohali facility will cater to the US and other geographies, improving access to medicines, in these regions."

Ranbaxy's dosage forms facility at Mohali was approved by the US Food and Drug Administration in October 2011, after having been banned in 2009 over compliance issues, following a ban of 30 products from it Paonta Sahib and Dewas facilities in 2008.

In December Ranbaxy said it had signed a consent decree with the US FDA and agreed to provide for $500 million to resolve any potential civil and criminal liability.

In the first quarter of 2012, the company received approval from the US FDA to manufacture and market atorvastatin 10mg, 20mg, 40mg and 80mg tablets. Earlier, international regulatory authorities such as the WHO-Geneva, National Medicine and Medical Devices Agency (NMMDA)-Romania, ANVISA-Brazil, TGA-Australia, Canada Health-Canada etc. had also given their approval to the company's Mohali facility.

The new facility at Mohali will manufacture oral solid products for export to US, EU and other countries based on filings and after receiving the necessary approvals.