The United States Food and Drug Administration (USFDA) has successfully concluded inspection at Unichem Laboratories’ newly commissioned Active Pharmaceutical Ingredients (APIs) facility at Kolhapur in Maharashtra without any FDA form 483 issued.
The inspection was conducted from September 16, 2019 to September 20, 2019. The inspection was a cGMP surveillance and pre-approval inspection.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It 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.
