In a regulatory filing made before market hours today, the drug maker informed that the U.S. Food and Drug Administration (US FDA) had conducted an inspection at the company's formulations manufacturing unit at Piparia (Silvassa) from 18th to 26th of April 2023.

At the end of the inspection the US FDA issued a form 483 with three observations.

"The company will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest,” Ipca Laboratories said in a statement.

Ipca is a pharmaceutical company with a thrust on exports which now account for 44% of the company's income. Ipca is vertically integrated and produces finished dosage forms and active pharmaceutical ingredients.

The company's consolidated net profit tumbled 45.25% to Rs 107.84 crore in Q3 FY23 compared with Rs 196.96 crore in Q3 FY22. Revenue from operations rose 8.08% YoY to Rs 1,546 crore in the corresponding quarter last year.

The scrip of Ipca Labs is currently trading 0.56% higher from its 52-week low of Rs 687 hit yesterday (26 April 2023).