INDIAN FIRMS REPORT US FDA SUBMISSIONS, TARGET NEW MARKETS
Indian generics firms claim to have filed over 143 Drug Master Files (DMFs) with the US FDA in the first half of 2005, equivalent to 35% of all DMFs registered in the period. The submissions come ahead of patent expirations on drugs expected to be worth roughly US$50bn per year by year-end 2010.
India's generics market is worth US$3.3bn and accounts for the overwhelming majority of domestic consumption, but growing numbers of producers are fleeing tough competition at home for new opportunities in the US and Europe. However, price pressures in these markets and multinational production of "authorised generics" have seen prices tumbling in recent years.
As a result, Indian generics exporters are increasingly looking toward emerging
markets to sell their products. Africa is particularly attractive, as it has
limited local manufacturing and subsequently a great demand for low-cost generic
products. However, the markets in South America and Southeast Asia where
prices and volumes are higher are also being targeted. Recent months
have also seen the entry of major Indian pharmaceuticals producers in Eastern