Laurus Labs gets Form 483 with 1 observation from USFDA

Laurus Labs announced that the US FDA has issued Form 483 with one observation after the pre-approval inspection of its Visakhapatnam facility.

The announcement was made on Friday, post market hours.

The drug maker said that its manufacturing facility at Parawada, Visakhapatnam, Andhra Pradesh was inspected by United States Food and Drug Administration (USFDA) from 24 October 2022 to 28 October 2022.

At the end of the inspection, the pharmaceutical company was issued a Form 483 with one observation by the US drug regulator. The observation is procedural in nature, the pharma company stated.

The pharma major added that it will address the observation within stipulated timelines.

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, Hepatitis C, and oncology drugs.

The pharmaceutical company posted a 15% rise in consolidated net profit to Rs 233 crore on a 31% increase in revenue from operations to Rs 1,230 crore in Q2 FY23 over Q2 FY21.

Shares of Laurus Labs rose 0.82% to Rs 448.30 on the BSE.

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