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USFDA completes inspection at Aurolife Pharma LLC's Raleigh Unit

Posted On : 2022-08-29 12:46:50( TIMEZONE : IST )

USFDA completes inspection at Aurolife Pharma LLC's Raleigh Unit

The United States Food and Drug Administration (US FDA) conducted its pre-approval inspection (PAI) and GMP inspection from August 22 to August 26, 2022, of Aurolife Pharma LLC's Unit at Raleigh, North Carolina, USA, established for manufacturing MDI (Metered Dose Inhalers) and Derma products.

The Unit has filed 2 Derma products and 1 MDI product.

At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues. We will respond to the US FDA within the stipulated timeline and work closely with US FDA to address the observation at the earliest.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 549.90 as compared to the previous close of Rs. 555.70. The total number of shares traded during the day was 49571 in over 3082 trades.

The stock hit an intraday high of Rs. 558.55 and intraday low of 549.00. The net turnover during the day was Rs. 27425537.00.

Source : Equity Bulls


AurobindoPharma INE406A01037 AurolifePharmaLLC USFDA PreApprovalInspection GMPInspection Raleigh NorthCarolina