By: IPP Bureau
Last updated : June 29, 2025 7:29 pm
Granules India receives 1 observation from USFDA for Chantilly facility
Neuland Laboratories receives EIR from USFDA for Unit 2 at Pashamylaram Village
The U.S.FDA has issued an Establishment Inspection Report (EIR) against the Inspection conducted at our Unit 2 manufacturing facility, located at Pashamylaram village, Sangareddy District, from April 28, 2025 to May 2, 2025.
Granules India 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, a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA from 23rd June 2025 to 27th June 2025 with one 483 observation. Granules Pharmaceuticals, Inc. addressed and resolved the observation during the inspection.