Granules India Metformin ANDA Receives FDA Nod

The ANDA, which was developed and registered by Granules, is in collaboration with Heritage Pharmaceuticals, a generic pharmaceutical company. Under a previous agreement, Heritage retains exclusive sales and marketing rights to the Metformin ANDA for several years.

Metformin is an oral anti-diabetic drug in the biguanide class. It is the drug of choice for the treatment of type 2 diabetes, particularly in overweight and obese people and those with normal kidney function. It is also used in the treatment of polycystic ovary syndrome and has been investigated for other diseases where insulin resistance may be an important factor.

Krishna Prasad, managing director at Granules India, said: “Our, FDA approved, formulation facility combined with several pending ANDA’s demonstrates Granules is making inroads into the formulation segment. We will continue to focus on filing more ANDA’s in the future in order to better target the US market.”