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Ajanta Pharma gets USFDA Form 483 with five observations at Paithan plant
22-Apr-2026 | 10:06
Ajanta Pharma said the United States Food and Drug Administration (USFDA) has completed an inspection at its Paithan manufacturing facility in Maharashtra, conducted between 13 April and 21 April 2026.
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.
