Granules India announced that it has received an establishment inspection report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Unit V facility located at Jawaharlal Nehru Pharma City (JNPC), Anakapalli, Andhra Pradesh.
This US drug regulator conducted an inspection from 8 April to 12 April 2024. Now, the inspection is classified as No Action Indicated (NAI), indicating compliance with current Good Manufacturing Practices (cGMP) standards and confirming that no further regulatory action is required.
This outcome reflects the facility's high standards in the production of Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for both oncology and non-oncology therapeutic areas, said the drug regulator.
During the inspection, the FDA conducted a comprehensive pre-approval inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations.
Krishna Prasad Chigurupati, chairman & managing director of Granules India said, "The successful completion of this US FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our unwavering commitment to maintaining the highest quality standards in our manufacturing operations."
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Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).
Granules India consolidated net profit fell 4.79% to Rs 97.23 crore on 18.74% declined in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24.
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