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The inspection concluded with five observations, all pertaining to procedural changes, with none related to data integrity.
The company said it will submit the required response to the USFDA within the stipulated 15-day period.
Unichem Laboratories is engaged in manufacturing of pharmaceutical products.
The company’s consolidated jumped 83.9% to Rs 45.30 crore on 14.1% increase in net sales to Rs 578.96 crore in Q2 FY26 over Q2 FY25.
Shares of Unichem Laboratories rose 0.16% to Rs 374.65 on the BSE.