Aurobindo Pharma drops 3% as USFDA issues 'Form 483' to US arm unit

Shares of Aurobindo Pharma were trading over 3 per cent lower in Monday's trade after the United States Food and Drug Administration (USFDA) conducted its pre-approval inspection (PAI) and GMP inspection of a unit of wholly-owned step-down US subsidiary Aurolife Pharma LLC and issued form 483 with one observation.

The unit is situated at Raleigh, North Carolina and was inspected from August 22 to August 26, 2022.

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


Following the development, the stock fell 3.23 per cent to hit a low of Rs 532.10 on BSE.

The US unit manufactures MDI (Metered Dose Inhalers) and derma products. The unit has filed two Derma products and one MDI product.