Laurus Labs’ wholly-owned foreign subsidiary -- Laurus Generics Inc. (LGI) has undergone a Post-marketing Adverse Drug Experience (PADE) inspection by USFDA. The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Laurus Labs marketed products worldwide.
The inspection was conducted for four days between January 13, 2025 to January 21, 2025. It has been issued a Form 483 with one observation and the company will address the said 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.
