USFDA completes inspection at Aurolife Pharma's Raleigh Unit

29 Aug 2022 , 03:17 PM

Aurobindo Pharma Limited informed on Monday that 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”, the company said.

At around 3:15 PM, Aurobindo Pharma Ltd traded at Rs540.40 per share down by Rs9.5 or 1.73% from its previous closing of Rs549.90 per share on the BSE.

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