In a regulatory filing made after market hours on Friday (26 May 2023), the drug maker said that the United States Food and Drug Administration (US FDA) had inspected the company's Unit 3 manufacturing facility, located at Gaddapotharam village, Jinnaram, Sangareddy District, Telangana, from 22nd to 26th of May 2023.

The inspection has been concluded with 3 observations (minor) given under form 483, which are relating to procedures.

"The company has already initiated corrective and preventive actions for the observations and is confident of addressing the same to the satisfaction of the US FDA within the stipulated time,” Neuland Labs said in a statement.

Neuland Laboratories is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry's chemistry needs. It provides solutions across the full range of the pharmaceutical industry's chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life-cycle, as well as commercial launch.

The company's consolidated net profit stood at Rs 84.54 crore, steeply higher from Rs 21.78 crore posted in Q4 FY22. Revenue from operations jumped 59.09% to Rs407.07 crore in Q4 FY23 as compared with Rs 255.87 crore in Q4 FY22.