Granules India Ltd., a vertically integrated formulation manufacturer, has bagged the  US Food and Drug Administration (FDA) approval for its  Abbreviated New Drug Application (ANDA) for naproxen sodium 220mg.

Naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID), is used to reduce pain, fever and inflammation. The drug is sold under various brand names such as Aleve and Midol in the US.  Annual sales for branded naproxen sodium tablets and caplets in the US exceeded $200 million for the twelve months ending March 31, 2011 according to SymphonyIRI Group.

Granules is in active discussions with several US generics drug manufacturers and expects commercial orders for naproxen sodium finished dosages to commence in the first half of 2012.

According to  C Krishna Prasad, managing director at Granules India, the  approval is another significant step in our effort of becoming the leading formulation manufacturer of high-volume products. We have an efficient facilities that excel in large-scale manufacturing so we are keen to offer naproxen sodium which is used in more than six billion doses per year. We will build on our momentum by filing global applications for several more products in order to extend our market penetration.”

Granules is partnering with market leaders to offer pharmaceutical products and services. The company is recognized as a producer of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages(FDs). “Our integrated model allows us to provide products throughout the value chain in a cost-effective and efficient manner. We serve over 300 customers in 50 countries through our sales offices in India, US, UK, Colombia and China,” he added.