Aurobindo Pharma Ltd received US FDA approval for its Abbreviated New Drug Application (ANDA) for Metformin. Metformin is indicated in the treatment of diabetes.
With this approval, the Company has received its 3rd product approval from US FDA for marketing in the USA and looks forward for more to come in the near future, a company release said.
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, the release added.
The company has accelerated the DMF / ANDA filing programme and the company has filed 11 DMFs (cumulative-64) and five ANDAs / formulation dossier filings (cumulative-15) in the US and EU in the third quarter of financial year 2004-'05.
In US alone, the company has filed 7 DMFs (cumulative-22) and five ANDAs (cumulative-11) in the quarter.
The company achieved another milestone with its Unit-8 being inspected by US FDA without receiving any Form 483 queries. The unit is located near Hyderabad and manufactures APIs and comprises three manufacturing blocks. The company has filed six DMFs from this unit in the therapeutic segments such as CVS, CNS and anti-retrovirals.