Shares of Aurobindo Pharma rose 2% to test a 52-week high of Rs 860.85 on Aug 7 after the company was approved for the drug by the US Food and Drug Administration (FDA). vancomycin hydrochloride injection.
At 09:52, Aurobindo Pharma was trading at Rs 859.95, up Rs 18.15, or 2.16% on BSE.
The Company’s wholly owned subsidiary, Eugia Pharma Specialties, has received final US FDA approval to manufacture and market Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1 ,5 g/vial, single dose.
This drug is bioequivalent and therapeutically equivalent to the Reference Drug (RLD), Vancomycin Hydrochloride for Injection USP, from Mylan Laboratories.
The product will be launched in August 2023. The company says this is the 164th ANDA (including eight tentative approvals) for the Eugia Pharmaceutical Specialty Group (EPSG) facilities, which produces both oral and sterile specialty products.
Vancomycin Hydrochloride for Injection USP is indicated in adults and pediatric patients (newborns and older) for the treatment of sepsis, infective endocarditis, skin and skin structure infections, bone infections, and respiratory tract infections lower steam. On August 4, the US FDA conducted a Pre-Approval Inspection (PAI) at the company’s Unit VII, a formulation factory located at Jedcherla Mandal, Mahaboob Nagar district, Telangana, from the 28th. July to August 4, 2023.
The aforesaid inspection ended with no observations and a no-action assigned (NAI) classification.
The Company’s Board of Directors will meet on 12 August 2023 to review and approve the Company’s unaudited separate and consolidated financial results for the first quarter ended 30 June 2013. 2023.
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