The drug maker said it does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.
The US Food and Drug Administration (USFDA) inspected the Glenmark's Goa facility in May 2022 and issued Official Action Indicated (OAI). The drug regulator has now issued a warning letter to the Goa facility."The Company is committed to work along with the US FDA to implement all the necessary corrective actions required to address the concerns at the earliest. The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe," Glenmark said in a statement.
Glenmark Pharmaceuticals is primarily engaged in the business of development, manufacture and marketing of pharmaceutical products.
On consolidated basis, the company's net profit rose 1.1% to Rs 260.44 crore on 6% jump in net sales to Rs 3,312.49 crore in Q2 FY23 over Q2 FY22.
The scrip was down 0.38% to Rs 423.75 on the BSE.
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