Granules India, a vertically integrated formulation manufacturer, has received US FDA approval for Metformin 500mg, 850mg and 1000mg. The ANDA, which was developed and registered by Granules, is in collaboration with Heritage Pharmaceuticals Inc. Under a previously announced agreement, Heritage retains exclusive sales and marketing rights to the Meformin ANDA for several years. Both parties will share net profits from product sales.
“Receiving approval for our first ANDA is an exciting step in our effort of becoming a leading formulation manufacturer. Our US FDA approved formulation facility combined with several pending ANDAs demonstrates Granules is making strong inroads into the formulation segment. We will continue to focus on filing more ANDAs in the future in order to better target the lucrative US market,” said C Krishna Prasad, managing director at Granules India.