Drugmaker Granules India has received an establishment inspection report (EIR) from the U.S. Food and Drug Administration for its Unit V manufacturing facility in JNPC, Anakapalli district of Andhra Pradesh.
The U.S. FDA inspection classified the facility as ‘No Action Indicated’ (NAI), indicating compliance with current good manufacturing practices (cGMP) standards and confirming no further regulatory action is required. The 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, the company said in a release on Friday.
From April 8-12, the U.S. FDA had conducted a comprehensive pre-approval inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations, Granules said.
“The successful completion of this U.S. FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our commitment to maintaining highest quality standards in our manufacturing operations,” Chairman and Managing Director Krishna Prasad Chigurupati said. Granules shares closed 1.98% higher at ₹582.90 each on the BSE.
Published – November 08, 2024 10:14 pm IST
