Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility

Granules India announced that Granules Consumer Health (GCH), a step- down subsidiary of the Company and a wholly owned subsidiary of Granules USA, Inc., has completed an audit by the U.S. Food and Drug Administration (USFDA) with zero 483s.

The facility was inspected by the USFDA from 15-20th March 2023.

“The audit is a pre-approval inspection for three products filed from the facility. The packaging site strengthens our proposition to control the value chain and provides us with the agility needed in a very dynamic OTC space,” said Priyanka Chigurupati, Executive Director, Granules USA, Inc. & Granules Pharmaceuticals, Inc.

GCH is a leading private-label OTC provider, and its packaging facility will enable it to service leading retailers more effectively.

The packaging facility in Manassas is spread over 79,000 square feet and has several packaging suites to service customer needs. Granules Consumer Health was established in 2014, to offer OTC generics that meet the highest level of quality at an affordable cost.