Aurobindo Pharma Limited on Saturday announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vancomycin Hydrochloride for Injection USP, by Mylan Laboratories Ltd., the company announced through an exchange filing.
The product is being launched in August 2023.
The approved product has an estimated market size of around US$ 34.4 million for the twelve months ending May 2023, according to IQVIA.
This is the 164th ANDA (including 8 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Vancomycin Hydrochloride for Injection USP is indicated in adults and paediatric patients (neonates and older) for the treatment of Septicemia, Infective Endocarditis, Skin and Skin Structure Infections, Bone Infections and Lower Respiratory Tract Infections.
Aurobindo Pharma shares
The shares of Aurobindo Pharma on Friday at 3:30 pm IST were at Rs 840, down by 0.042 percent.