Granules India’s active pharmaceutical ingredient Unit-1 in Bonthapally, Hyderabad, one of the largest single-site paracetamol API manufacturing plants by volume globally, has received U.S. Food and Drug Administration’s establishment inspection report with a voluntary action indicated (VAI) classification.
The U.S. FDA had issued one observation following an inspection of the facility in June. The company submitted its response within the stipulated time, the generic drugmaker said on Wednesday, announcing receipt of the EIR.
Along with Paracetamol APIs, the company has established Metformin and Guaifenesin API manufacturing plants in the same facility, it said. Granules shares closed less than 1% higher at Rs.571.25 apiece on the BSE.
“The successful completion of this U.S. FDA inspection and the subsequent receipt of the EIR with a satisfactory VAI classification reflects our commitment to maintaining the highest quality standards in manufacturing operations,” Chairman and Managing Director Krishna Prasad Chigurupati said in a release.
VAI is one of the three classifications the U.S. FDA issues, as part of the EIR, to determine the outcome of its inspection. VAI means objectionable conditions or practices were found, but the regulator is not prepared to take or recommend any administrative or regulatory action.
No action indicated or NAI is another classification, which means no objectionable conditions or practices were found during the inspection. The third category of classification is official action indicated (OAI) that means regulatory and/or administrative actions are recommended.
Published – October 29, 2025 10:53 pm IST
