Mukesh Ambani-promoted Reliance Pharmaceuticals Pvt Ltd is putting together a comprehensive plan for an incisive entry into the regulated US and European markets with high-value generics. Also on board will be active pharmaceutical ingredients (APIs) and formulations for the non-regulated markets outside India.
The company has identified the first set of 6 formulations to be manufactured and marketed in non-regulated countries. But it is at the drawing-board stage to identify the generic drugs, which will number close to 10 at the beginning. The company will soon start filing ANDAs (abbreviated new drug applications) for review and approval of its generic products with the USFDA.
It is estimated that $64-$100 billion worth of drugs will lose their patents protection in the next five years, opening them to competition from generic companies across the world.
The formulations, mostly targeted at the high-value lifestyle diseases segment, are expected to be developed at the company?s research and development centre at Rabale, Navi Mumbai, in another six months. They will then be manufactured at the company?s upcoming plant in Jamnagar, Gujarat, according to people in the know of things. The first phase of the Jamnagar plant is expected to be commissioned by May 2008, and products are expected to roll out by 2008-end.
Reliance Pharma has made two high-level appointments in R&D?Rajan Gupte, a former Kopran scientist, and S Rajagopalan. Gupte will head API research and Rajagopalan will drive formulations.The company has also started registering these products in the non-regulated markets, including the CIS countries.