Eugia Pharma receives USFDA Approval for Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, Single-Dose vials

Aurobindo Pharma Limited has 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 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.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 841.80 as compared to the previous close of Rs. 840.30. The total number of shares traded during the day was 48419 in over 1884 trades.

The stock hit an intraday high of Rs. 855.40 and intraday low of 832.10. The net turnover during the day was Rs. 40801904.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 EugiaPharmaSpecialities FinalApproval USFDA VancomycinHydrochloride