7 Aug 2023 , 11:37 AM
On August 7, Aurobindo Pharma shares rose about 3% to a 52-week high of Rs 864.90 on NSE after the company received approval from the United States Food and Drug Administration (USFDA) for Vancomycin Hydrochloride injectable.
At around 11.20 AM, Aurobindo Pharma was trading 2.44% higher at Rs 862.15, against the previous close of Rs 841.55 on NSE.
Eugia Pharma Specialities, the company’s wholly-owned subsidiary, has received the final USFDA approval to produce and market Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, Single-Dose Vial.
The stated drug is bioequivalent and therapeutically equivalent to Mylan Laboratories’ reference listed drug (RLD), Vancomycin Hydrochloride for Injection USP.
The company plans to launch the product in August 2023.
According to the business, this is the 164th ANDA (including 8 tentative approvals) from Eugia Pharma Speciality Group (EPSG) facilities, which manufacture both oral and sterile specialty pharmaceuticals.
From July 28 to August 4, 2023, the USFDA recently undertook a pre-approval inspection (PAI) at the company’s unit VII, a formulation manufacturing plant located in Jedcherla Mandal, Mahaboob Nagar District, Telangana.
Further, the company’s board meeting is scheduled to be held on August 12, 2023, to consider and approve the consolidated and standalone financial results for the June quarter.
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