Aurobindo Pharma falls 2.5% after USFDA observation on Telangana unit

We will respond to the USFDA within the stipulated timelines and work closely with USFDA to close the observation at the earliest, company said.

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The share price of Aurobindo Pharma fell 2.5 percent in early trade on October 3 after the US Food and Drug Administration (USFDA) issued one observation for its Telangana facility.

At 9:25am, Aurobindo Pharma was quoting Rs 891.00, down Rs 23.20, or 2.54 percent, on the BSE.

The USFDA inspected the Unit VI-B, a formulation manufacturing facility of the company at Chitkul village in Sangareddy district of Telangana, during September 22 to 29.

At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature. “We will respond to the US FDA within the stipulated timelines and work closely with the US FDA to close the observation at the earliest,” the company said.

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The company has completed the sale or transfer of the its API Non Antibiotic Business and API Antibiotic Business to Apitoria Pharma Private Limited (formerly known as Auro Pharma India Private Limited), a wholly owned subsidiary of the company, on September 30 and consequently the API Non-Antibiotic Business and API Antibiotic Business shall be undertaken from Apitoria with effect from October 1,2023.

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

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