Ranbaxy applies for US FDA approval for Mohali plant; says WHO approves new ARV drug

India's largest pharma company Ranbaxy Laboratories is setting up a new manufacturing unit at its special economic zone in Mohali at an investment of Rs200 crore, for which it had appied to the US Food and Drug Administration to market its medicines manufactured from this plant to the US market.

This notwithstanding that three of Ranbaxy's US FDA-approved plants are already under investigation for allegedly not adhering to US standards and supplying fabricated information relating to the marketing these drugs in the US market.

Ranbaxy says it expects the new facility to be approved by the end of next year.

The company has aalso announced that the World Health Organisation  had approved and included another its anti retrovirals (ARV) drug in its pre-qualification list for the treatment of AIDS.

The product approved by WHO, Geneva , Abacavir 300mg tablets, will be manufactured at Ranbaxy's WHO pre-qualified manufacturing site at Paonta Sahib in Himachal.

With the inclusion of Abacavir 300 tablets, Ranbaxy now has 18 ARVs on the WHO pre-qualification list, including three USFDA approvals.
Abacavir is a nucleoside reverse transcriptase inhibitor and is widely used as part of first line anti retroviral treatment around the world.
''We are pleased to have one more product on the WHO pre-qualification list," said Malvinder Singh, CEO and managing director. "This is another significant step in our effort to offer high quality, affordable ARV medicines, for the benefit of the needy HIV patients in the developing and developed parts of the world. We remain committed to supporting the global fight against HIV/AIDS.''