In a regulatory filing made after market hours on Tuesday, the pharmaceutical company stated that its wholly owned subsidiary Laurus Synthesis (LSPL) had undergone a US FDA inspection for the manufacturing facility in Parawada, Anakapalli, near Visakhapatnam, Andhra Pradesh.

The inspection was conducted from 4th December, 2023 to 12th December, 2023. The company has been issued a Form 483 with five observations.

"The company will address the observations within stipulated timelines,” Laurus Labs said in a statement.

Laurus Labs is a fully integrated pharmaceutical and biotechnology company, with a leadership position in generic active pharmaceutical ingredients (APIs) and a major focus on anti-retroviral, oncology drugs, cardiovascular, gastro and hepatitis C therapeutics. The company also develops and manufactures oral solid formulations, provide contract research and manufacturing services (CRAMS) to global pharma companies.

The company's consolidated net profit declined 84.13% to Rs 36.95 crore on a 22.30% fall in sales to Rs 1,224.45 crore in Q2 FY24 as compared with Q2 FY23.