The Active Pharmaceutical Ingredients (API) facility of Dr Reddy’s Laboratories in Andhra Pradesh has successfully completed a Pre-Approval Inspection (PAI) and a routine GMP inspection by the US drug regulator.
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“The United States Food & Drug Administration (USFDA) today completed a Pre-Approval Inspection (PAI) and a routine GMP inspection at our API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh,’‘ Dr Reddy’s informed the BSE.
“The inspection was conducted from July 10-19, 2023. The inspection closed with zero observations and a classification of No Action Indicated (NAI),’‘ the Hyderabad-based company said in a release.