Aurobindo Pharma has received the US FDA approval for its Abbreviated New Drug Application (ANDA) for Mirtazapine tablets 7.5 mg, 15 mg, 30 mg and 45 mg. Mirtazapine tablets are indicated for the treatment of major depressive disorders.
The active pharma ingredient (API) is manufactured at the company's Unit 1 and the formulation is manufactured at Unit 3 obtaining the product and facility approvals for large API and formulations units without any 483 in less than one year.
Aurobindo has filed over 15 drug master files in the recent past in its effort to build a broad product portfolio for the US market. The company has also filed six ANDAs with US FDA. It is focusing mainly on antibiotics, anti-retrovirals, cardiovascular, CNS, gatro-enterologicals and anti-allergicals.