Aurobindo Pharma shares hit 52-week high on US FDA approval for drug to treat infection

The company’s board of directors will meet on August 12, 2023, to consider and approve the standalone and consolidated unaudited financial results of the company for the first quarter ended June 30, 2023.

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Aurobindo Pharma shares were up 2 percent to test 52-week high of Rs 860.85 on August 7 after company received approval from the United States Food and Drug Administration (US FDA) for Vancomycin Hydrochloride injection.

At 09:52 am Aurobindo Pharma was quoting at Rs 859.95, up Rs 18.15, or 2.16 percent on the BSE.

The company’s wholly owned subsidiary company, Eugia Pharma Specialities, has received a final approval from the US FDA to manufacture and market Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, Single-Dose Vial.

The said is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vancomycin Hydrochloride for Injection USP, by Mylan Laboratories.

The product is being launched in August 2023.

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, the company said.

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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On August 4, US FDA completed a pre-approval inspection (PAI) at company’s unit VII, a formulation manufacturing facility situated at Jedcherla Mandal, Mahaboob Nagar District, Telangana, from July 28 to August 4, 2023.

The said inspection closed with zero observations and a classification of no action indicated (NAI).

The company’s board of directors will meet on August 12, 2023, to consider and approve the standalone and consolidated unaudited financial results of the company for the first quarter ended June 30, 2023.