Dr Reddy’s Hyderabad API Unit Gets USFDA VAI Classification

25 Feb 2025 , 08:42 PM

Dr Reddy’s Laboratories Ltd said on Tuesday, February 25, that the USFDA has communicated to it that there are certain issues at the active pharmaceutical ingredient (API) manufacturing facility (CTO-2) at Bollaram in Hyderabad.

USFDA issued an Establishment Inspection Report (EIR) following an inspection of the facility, the company said in a filing. The USFDA classified the inspection as Voluntary Action Indicated (VAI), which means that it found some questions of concern but won’t take an immediate regulatory action.

The company in question, however, under a VAI classification is required to address and rectify the identified concerns voluntarily so as to be compliant with the USFDA standards. The inspection has now been classified as “closed” by USFDA, the regulatory filing added.

Dr Reddy’s Laboratories third quarter net profit rose 2.5% year-on-year (YoY) to ₹1,413.3 crore.  It had a net profit of ₹1,379 crore in the same quarter last fiscal.

Revenue from operations jumped 15.9% on-year (YoY) to ₹8,358.6 crore against ₹7,215 crore in the quarter ended March 2022. The company’s EBITDA for the quarter grew 8.9% YoY at ₹2,298.2 crore, against ₹2,111 crore in Q3 FY24. Currently, Dr Reddy’s Laboratories concentrates on resolving regulatory issues at its Hyderabad plant and also on enhancing its financials in the pharma domain.