Granules India’s Unit V facility in Andhra Pradesh gets US FDA EIR with NAI status

HYDERABAD: Pharma player Granules India Limited on Friday said it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Unit V facility located at Jawaharlal Nehru Pharma City (JNPC) in Anakapalli district of Andhra Pradesh’s Parawada Mandal.

The EIR follows an inspection conducted by the US FDA from April 8 to 12, 2024. The unit is a multi active pharmaceutical ingredients manufacturing facility that manufactures small to medium volume APIs which are forward integrated into the company's finished dosages and sold to third party customesr.

The US FDA inspection has classified the facility as `No Action Indicated’ (NAI), indicating compliance with current good manufacturing practices (cGMP) standards and confirming that no further regulatory action is required, the company said in a regulatory filing with the bourses.

During the inspection, the FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations, the company said.

“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,” 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," said Granules India chairman & managing director Dr Krishna Prasad Chigurupati.