Auro Pharma slips as US plant gets Form 483 with one observation from USFDA

29 Aug 2022 , 12:12 PM

Aurolife Pharma LLC is a wholly owned step-down subsidiary of the company. The United States Food and Drug Administration (US FDA) conducted its pre-approval inspection (PAl) and GMP inspection from 22nd – 26th August 2022, of unit at Raleigh, North Carolina, USA. This plant was established for manufacturing MDl (Metered Dose Inhalers) and derma products and it has filed two derma products and onw MDl product. Post 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, said the company. ?We will respond to the US FDA within the stipulated timeline and work closely with US FDA to address the observation at the earliest,? Auro Pharma said in a statement. Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients. The pharmaceutical company reported 32.4% fall in consolidated net profit to Rs 520.5 crore in Q1 FY23 from Rs 770 crore in Q1 FY22. Revenue from operations increased 9.4% YoY to Rs 6,235.9 crore Q1 FY23. Powered by Capital Market – Live News