USFDA issues 3 observations for Granules India Gagillapur facility

Written by Ruchika Sharma Published On 2023-01-16T14:30:28+05:30 | Updated On 16 Jan 2023 2:30 PM IST

USFDA issues 3 observations for Granules India Gagillapur facility

Hyderabad: Granules India has recently announced that US Food and Drug Administration (USFDA) has concluded Pre-Approval Inspection (PAI) with three observations at the company's Gagillapur facility.

The facility was inspected from 9th January 2023 to 13th January 2023.

"Please be informed that Company’s Gagillapur facility located at Hyderabad, Telangana, India has completed the US FDA’s Pre-Approval Inspection (PAI) from 9th January 2023 to 13th January 2023 with 3(three) observations, and the Company will respond to these observations within the stipulated time period," Granules stated in BSE filing.

Gagillapur facility manufactures Finished Dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs).

Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.

Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets

granulesgranules indiaUSFDAUSFDA inspectionGagillapur facility

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751