Emerging trends in API for DMF filings in the US
THE Indian active pharmaceutical industry is the largest component of the Indian pharmaceuticals sector in terms of both value and volume according to report by IBEF published in January 2016.The growth drivers for the Indian API have been two- fold. The primary demand for is catering to the domestic market where the same are used for the manufacture of cost effective generic medicines for local population consumption and the second area which is related to the outsourcing aspect of the market.
According to ICRA reports till the year 2012, there has been a rise in DMF fillings by domestic pharmaceutical and bulk drug companies reflect the growing presence of Indian manufacturers in the regulated markets. The growth is supported by heightened regulatory compliance amongst Indian companies with numerous US FDA approved manufacturing facilities, large talent pool and low cost of manufacturing.