Hyderabad: Aparna Pharmaceuticals Private Limited, a manufacturer of Active Pharmaceutical Ingredients (APIs) and Advanced Drug Intermediates announced that its manufacturing facility, Aparna Organics Limited, located at Pydibhimavaram in Srikakulam, Andhra Pradesh has received VAI (Voluntary Action Indicated) classification from the United States Food and Drug Administration (USFDA). The USFDA audited the facility in September 2023. A VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
Rakesh Reddy, Managing Director, Aparna Pharmaceuticals, said: “Our facility’s compliance journey has been meticulous. We are thrilled to receive the USFDA’s stamp of approval. We are excited to contribute to global healthcare by delivering high quality pharmaceutical APIs and intermediates.”
Reddy further said that, “With the successful completion of the FDA audit, Aparna Pharmaceuticals has emerged as a leading manufacturer of APIs.”
