Aurobindo Pharma Ltd has announced that U.S. Food Drug Administration (US FDA) has approved its Cephalexin capsules USP 250 mg & 500 mg.
Cephalexin is used to treat many different types of bacterial infections such as bronchitis, tonsillitis, ear infections, skin infections, and urinary tract infections.
The company has achieved another major milestone by obtaining the first product approval from the dedicated Cephalosporin facility (Unit VI, situated in Medak District, Andhra Pradesh, India).
The company has set up three (Unit III, Unit VI, Unit XII) multi module formulation manufacturing facilities. Earlier products from Unit III only contributed to the sales in the US. Product approvals from Unit XII and Unit VI have just come, and the company will be in a position to capitalise on this opportunity with immediate effect.
The market opportunity for the Cephalexin capsules USP 250 mg and 500 mg is around $80 million. The company is a leader in this segment in several markets in the world and is looking forward to market its products in the US.