The United States Food and Drug Administration (US FDA) had inspected company's Sterile Facility (Plant II) located at Goa from 20 to 28 of February 2023. The said Facility had 4 observations in Form 483.

The American drug regulator has determined the inspection classification of this facility as OAI (Official Action Indicated), the company stated.

Commenting on the developments, Aditi Panandikar, managing director, said: “We have done considerable remediation work and shall continue to implement necessary additional corrective actions. We are committed to being cGMP compliant and supplying quality products to our customers and patients across the globe.

Further, we believe that this inspection classification will not have an impact on existing supplies or revenues from this Facility.”

Indoco Remedies is engaged in the manufacturing and marketing of Formulations (finished dosage forms) and active pharmaceutical ingredients (APIs).

The pharmaceutical company's standalone net profit tumbled 37.16% to Rs 25.37 crore in Q4 FY23 from Rs 40.37 crore recorded in Q4 FY22. Revenue from operations grew by 6.94% year on year to Rs 428.05 crore in the quarter ended 31 March 2023.