Aurobindo Pharma shares hit a 52-week high after US FDAs approval
The shares, at 10:36 am, are trading up 1.81 per cent at Rs 857.00 to hit a 52-week high. The days high so far has been Rs 864.45.
Aurobindo Pharma shares hit a 52-week high after the pharma company got the go-ahead from the United States Food and Drug Administration (US FDA) for its Vancomycin Hydrochloride injection, a medicine to cure infections.
The shares, at 10:36 am, are trading up 1.81 per cent at Rs 857.00 each to hit a 52-week high. The day's high so far has been Rs 864.45.
The huge jump in the shares is most likely the reflection of the USFDA's approval for Aurobindo Pharma's subsidiary company, Eugia Pharma Specialities, to manufacture and market Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, single-dose vial.
The product is set to be launched in August 2023.
The company said in its BSE filing that the injection's single dose is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vancomycin
Hydrochloride for Injection USP, by Mylan Laboratories Ltd. Aurobindo Pharma informed that the approved product has an estimated market size of around US$ 34.4 million for the 12 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.
How the injection will be used
The company says 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.
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