Granules India Ltd receives 1 observation from USFDA for Chantilly facility

The US FDA has completed a Pre-Approval Inspection (PAI) for a first to file controlled substance ANDA at the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA from 23rd June 2025 to 27th June 2025 with one(1) 483 observation. Granules Pharmaceuticals, Inc. addressed and resolved the observation during the inspection.

Shares of Granules India Limited was last trading in BSE at Rs. 497.30 as compared to the previous close of Rs. 497.15. The total number of shares traded during the day was 26069 in over 1221 trades.

The stock hit an intraday high of Rs. 503.05 and intraday low of 495.50. The net turnover during the day was Rs. 13014484.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 GranulesPharmaceuticalsInc USFDA PreApprovalInspection ANDA Chantilly Form483 1Observation