Unichem Laboratories has received four observations from the US Food and Drug Administration (USFDA) for its API manufacturing facility at Roha, Maharashtra. The facility was inspected by USFDA from July 30, 2018 to August 03, 2018.
Four observations were made which do not impact continuity of the company's business and its manufacturing activity. The company proposes to respond to these observations within 15 business days. The Roha facility manufactures API for use in the production of formulations that are exported to the USA.
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.
