US Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at Laurus Labs’ manufacturing facility at Unit-5, Parawada, Visakhapatnam, Andhra Pradesh. The inspection was conducted from October 24, 2022 to October 28, 2022. The company has been issued a Form 483 with one observation. The observation is procedural in nature. The company will address the observation within stipulated timelines.
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.
