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The inspection was conducted from 20 February 2023 to 28 February 2023. The USFDA has issued Form 483 with four observations.
Indoco Remedies said that the observations will be addressed within stipulated time.
"We believe that this will not have an impact on the supplies and the existing revenues from this facility," the company said.
Indoco added that it is committed to maintain compliances across all its facilities with cGMP quality standards at all times.
Indoco Remedies is engaged in the manufacturing and marketing of Formulations (finished dosage forms) and active pharmaceutical ingredients (APIs). The company's consolidated net profit declined 14.7% to Rs 28.15 crore despite of 17.9% rise in net sales to Rs 411.15 crore in Q3 FY23 over Q3 FY22.
The scrip rose 0.31% to currently trade at Rs 360.45 on the BSE.
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