The inspection concluded with the issuance of a Form 483 containing five observations. The company said it will respond to the US FDA within the stipulated timeline.

A Form 483 indicates procedural or compliance deficiencies noted during inspection and does not constitute a warning letter or import action at this stage.

Ajanta Pharma is primarily involved in development, manufacturing and marketing of speciality pharmaceutical finished dosages.

The company’s consolidated net profit jumped 17.6% to Rs 273.77 crore on 20% rise in revenue from operations to Rs 1,374.84 crore in Q3 FY26 over Q3 FY25.

Shares of Ajanta Pharma fell 0.41% to Rs 2,784.40 on the BSE.