1400 and still going strong! No certainly it is no sporting landmark in cricket. Neither it is score in nay indoor game. It is the score which signifies the number of pending ANDA applications from the Indian Pharma which are lying on the tables of the USFDA. This not only adds to the cost of healthcare of the consumer in the USA but also prevents the growth of the Indian Pharmaceutical industry.
Most of the Indian Pharma majors who submit their ANAD filings in the USA, have managed to "file less" in 2009 as compared to 2008..this backlog on part of the USFDA can potentially delay generic drug competition in both sets of product, both which are already off patent and are available as generics as well as those products which are going to go off patent. This is particularly affecting the growth of all those companies which are export dependent and in turn all those Outsourcing providers particularly CRO's which are dependent on them.