Generic drug manufacturer Unichem Laboratories said its formulations manufacturing facility at Ghaziabad has successfully exited an inspection by the US Food and Drug Administration.
It received an Establishment Inspection Report (EIR) from the USFDA, the company said.
“This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). The inspection has now been closed by the USFDA,” it said.
The inspection was carried out between 24″ Feb 2017 to 3″ March 2017.
Unichem Laboratories manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.
In India, the company focuses on aeas of cardiology, neurology, orthopedics and anti-infectives.
Like most generics companies, the US is Unichem’s most important market. The USFDA conducts on-spot inspections of manufacturing plants that are used to produce drugs sold in the United States.