US Food and Drug Administration (USFDA) has completed inspection at Laurus Labs’ FDF & API Integrated Facility, Unit 2, at Visakhapatnam. The inspection was carried out from November 04 - 08, 2019.
The company has been issued with two observations which are procedural in nature. This is a product pre-approval audit by USFDA.
Laurus Labs is a leading research and development driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of APIs for anti-retroviral (ARV) and Hepatitis C. It also manufactures APIs in oncology and other therapeutic areas.