The inspection concluded with zero 483 observations by the US drug regulator.
The pharmaceutical company said that its API manufacturing facility located at Hyderabad has completed the United States Food and Drug Administration (USFDA) inspection without any 483 observation.
The USFDA conducted the inspection from 9 September 2024 to 13 September 2024.
Laurus Labs’ API manufacturing facility, located at DS-1, IKP Knowledge Park, Genome Valley, Shameerpet, Telangana is instrumental in developing active pharmaceutical ingredients, bolstering the companys ability to deliver high-quality, innovative pharmaceutical solutions to its global customers.
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 companys consolidated net profit dropped 49.7% to Rs 12.51 crore in Q1 FY24 as against Rs 24.85 crore reported in Q1 FY24. Net sales was at Rs 1,194.91 crore in Q1 FY25, up 1.1% from Rs 1,181.79 crore recorded in the same period a year ago.
Shares of Laurus Labs shed 0.25% to settle at Rs 505.70 on Friday, 13 September 2024.
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First Published: Sep 14 2024 | 4:55 PM IST
