Ranbaxy Laboratories Limited, a subsidiary of Daiichi Sankyo Co of Japan, has commenced exports of atorvastatin calcium oral tablets to the US market, from its state-of-the-art Mohali SEZ manufacturing facility, located in Punjab, India.
The first consignment of atorvastatin tablets has been dispatched to the US market in March 2012. The supply of atrovastatin tablets from India supplements the company’s current production from Ohm Laboratories Inc, USA.
“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, ”said Arun Sawhney, CEO & managing director, Ranbaxy Laboratories.
Ranbaxy’s dosage forms facility at Mohali was approved by the US Food and Drug Administration (FDA) in October 2011. Thereafter, 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 approved 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. It is equipped with the latest state-of-the-art technology, designed to meet global and local regulatory requirement and conforms to cGMP standards.