Aavis Pharmaceuticals — an arm of Gujarat-based Espee Group — on Tuesday announced that it has received clearance from the US Food and Drug Administration (USFDA), for its facility in Hoschton, Georgia, with ‘Zero 483 observations’.
The company, which has already commissioned the facility, plans to serve as a Contract Development and Manufacturing Organisation (CDMO), offering a variety of pharmaceutical development and manufacturing solutions .
“With the successful inspection of its formulation manufacturing plant, Espee has become one of the top groups from Gujarat to have a USFDA-approved plant in the US. The company’s formulations facility was inspected by the USFDA for good manufacturing practices and PAI (Pre-Approval Inspection) in January 2019. The company received the Establishment Inspection Report (EIR) in February 2019, which concludes the inspection process,” the company said.