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Aurobindo Pharma Shares Tumble 6% as USFDA Issued One Observation

The facility was inspected between 22 - 29 September and was issued a Form 483 with one observation.

Aurobindo Pharma shares plummeted 6% and reached an intraday low of Rs 881.10 on 3 October after the USFDA (the US Food and Drug Administration) issued one observation for its Telangana facility.

The Unit VI-B was inspected by USFDA, a formulation manufacturing facility of the company located in the Chitkul village in the Sangareddy district of Telangana.

The facility was inspected between 22 – 29 September and was issued a Form 483 with one observation that is procedural in nature.

The company said, “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 has also received an EIR (Establishment Inspection Report) from the USFDA for its Unit-III, located in Telangana’s Bachupally village.

Aurobindo Pharma has successfully completed the sale or transfer of its API Antibiotic Business and API Non-Antibiotic Business on 30 September to its wholly-owned subsidiary, Apitoria Pharma Private Limited, previously known as Auro Pharma India Private Ltd.

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

At 10:50 am, the shares of Aurobindo Pharma were trading at Rs 884 or 3.32% below its previous close of Rs 914.35 on NSE.

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