Laurus Labs gets 2 USFDA observations for Visakhapatnam facility
New Delhi: Drug firm, Laurus Labs Ltd. recently said in a filing that the US health regulator has issued two observations after the inspection of its Unit – 2 (FDF&API integrated facility), located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
The US Food and Drug Administration (USFDA) inspection was carried out from 04 November 2019 to 08 November 2019.
"Laurus Labs Limited, a leading research and development-driven pharmaceutical company has completed the US Food and Drug Administration (USFDA) inspection of its Unit – 2 (FDF&API integrated facility), located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh, with two observations which are procedural in nature," Laurus Labs said in a filing.
"This is a product pre-approval audit by USFDA, and no data integrity issues were observed in the inspection," the company added.
Laurus Labs is a research & development driven and fully integrated pharmaceutical company in India. The Company is a manufacturer of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus also manufactures APIs in Oncology and other therapeutic areas.