Granules India arm gets 3 USFDA observations for Chantilly facility

Hyderabad: Granules India Limited announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in Chantilly, Virginia, USA has received three minor observations from the US Food and Drug Administration (USFDA).

The company had undergone a Preapproval Inspection (PAI) by the USFDA from 24th to 28th January 2022.

The audit is a PAI for two of its product applications filed from this facility. The USFDA issued three minor observations during the audit conducted at the facility.

Commenting on the audit Ms. Priyanka Chigurupati, Executive Director, GPI, said "We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period."

Earlier, Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company located in Chantilly, Virginia, USA had undergone a Pre-Approval Inspection (PAI) audit by the USFDA from 21st June 2021 to 25th June 2021.

Read also: Granules India Arm Clears USFDA Audit

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.

Read also: KVS Ram Rao appointed Granules India Joint MD, CEO