Ranbaxy Laboratories has announced that beginning in March 2012, the first shipments of atorvastatin, the generic version of Pfizer’s Lipitor, had been sent to US markets from its new Mohali manufacturing facility located in Punjab, India.
Ranbaxy had received approval from FDA in November 2011, to produce atorvastatin at its Ohm Laboratory site in the US, but its Paonta Sahib, Batamandi, and Dewas, India facilities have been on FDA import alert since 2008. According to the company’s press release, Ranbaxy’s Mohali facility was granted approval from FDA in October 2011 to manufacture and market atorvastatin 10-, 20-, 40-, and 80-mg tablets. Ranbaxy expects the Mohali facility to manufacture oral solid products for export to US, EU, and other countries based on filings and after receiving the necessary approvals.
Arun Sawhney, CEO and managing director of Ranbaxy, said in the release, “The resumption of supplies from India into the US market, is a significant milestone for Ranbaxy. This is a testimony to our commitment to provide quality affordable medicines to the US healthcare system. Going forward, our Mohali facility will cater to the US and other geographies, improving access to medicines, in these regions.”