Following a USFDA inspection of a Telangana unit, Aurobindo Pharma is down 2%

3 Oct 2023 , 02:18 PM

Early on October 3 after the US Food and Drug Administration (USFDA) issued one observation for its Telangana facility, the share price of Aurobindo Pharma dropped by 2%.

At 12:20 p.m., Aurobindo Pharma was trading on the BSE for Rs 894.60, down Rs 19.75 or 2.16%.

From September 22 to September 29, the USFDA visited the company’s Unit VI-B, a formulation production plant located in Chitkul Village in Telangana’s Sangareddy District.

At the conclusion of the inspection, a Form 483 was issued with one procedural observation. The company declared, ‘We will react to the US FDA within the specified dates and work together with the US FDA to close the observation as soon as possible.

On September 30, the company completed the sale or transfer of its API Non-Antibiotic Business and API Antibiotic Business to Apitoria Pharma Private Limited, a wholly owned subsidiary of the company (previously known as Auro Pharma India Private Limited). As a result, the API Non-Antibiotic Business and API Antibiotic Business will be conducted from Apitoria as of October 1, 2023.

The US regulator issued an Establishment Inspection Report (EIR) for its Unit-III in the Telangana village of Bachupally.

The American regulator has given the business’s fully owned subsidiary Eugia Pharma Specialities Limited final approval to produce and sell Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, Single-Dose Vials.

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