US Food and Drug Administration (USFDA) has completed, pre-approval inspection (PAI) at Laurus Labs’ API manufacturing 1&3 Units, located at J N Pharma City, Parawada, Visakhapatnam in the state of Andhra Pradesh.
The inspection ended with three observations, which are procedural in nature and no data integrity issues were observed in the inspection. The inspection was carried out from November 18, 2019 to November 21, 2019.
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.