Aurobindo Pharma to mkt Metformin in USA

Aurobindo Pharma has received USFDA (U.S. Food and Drug Administration) approval for its Abbreviated New Drug Application (ANDA) for Metformin. Metformin is indicated in the treatment of diabetes.

According to a release issued to the BSE, both Active Pharmaceutical Ingredients (API) and Formulation shall be manufactured in company's units and company has distinctive advantage of complete vertical integration in this product in India.
With this approval, the company has received its 3rd product approval from USFDA for marketing in the USA and looks forward for more to come in the near future. The product is one among the top products in terms of volume in USA.

The release added that the company has invested significant resources in building a mega infrastructure for API's and Formulations to emerge as a vertically integrated pharmaceutical company. The company's 4 units for API's and 4 units for Formulations, are designed for the regulated market. The company expects to reap the benefits of continuous product approvals from US/EU in the coming quarters.