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Aurobindo Pharma Shares Slip 2% as USFDA Raises Procedural and Cleanliness Issues

The production facility was granted approval under the Production Linked Incentive Program.

Shares of Aurobindo Pharma Ltd were trading in red and 2% lower on 15 March after the USFDA raised procedural and cleanliness issues at the company’s subsidiary, Eugia Pharma SEZ unit in Telangana.

The company said that its subsidiary’s Telangana plant was issued with seven observations in its Form 483 after the US regulator conducted an inspection of the unit between 19 February and 29 February.

USFDA said that the Telangana unit was not following the procedures to prevent contamination, and written records were not maintained, leading to unexplained discrepancies.

The US regulator also found that the equipment used were not suitably located to facilitate operations and the employees engaged in manufacturing and processing the drugs lack training. The plant did not have procedures to validate the performance of manufacturing processes and drugs.

Earlier on 29 February, the company restarted production in its terminally sterilised product lines at its Unit-III that was temporarily stopped to address some of the observations of the US FDA in their recent inspection.

At 3:30 pm, the shares of Aurobindo Pharma closed 1.04% lower at Rs 1,000.75 on NSE.

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