The US Food and Drug Administration (USFDA) had conducted good manufacturing practice (GMP) inspection at company's solid oral formulation facility (Plant 1) at Goa.
The inspection was conducted from 16 January 2023 to 20 January 2023. The USFDA has issued Form 483 with 9 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 Remedies is engaged in the manufacturing and marketing of Formulations (finished dosage forms) and active pharmaceutical ingredients (APIs). The company's consolidated net profit jumped 19.3% to Rs 49.73 crore on 8.6% rise in net sales to Rs 404.95 crore in Q2 FY23 over Q2 FY22.
The scrip was up 3.07% to Rs 403.25 on the BSE.
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