USFDA inspection: Glenmark Pharma gets warning letter for Goa facility

Published On 2022-11-24 07:00 GMT   |   Update On 2022-11-24 07:00 GMT
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Mumbai: Drugmaker Glenmark Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued a warning letter to the company's Goa facility.

The USFDA had inspected the facility in May 2022 and issued Official Action Indicated (OAI) status. Official Action Indicated (OAI) means regulatory and/or administrative actions will be recommended.
"The Company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility," Glenmark stated in a recent BSE filing.
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"The Company is committed to work along with the USFDA 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 added.

Medical Dialogues team had earlier reported that Glenmark Pharmaceuticals Inc., USA (Glenmark) and Glenmark Pharmaceuticals Limited had reached a settlement agreement with Pfizer Inc., PF Prism C.V., and PF Prism IMB B.V. for Axitinib Tablets, 1 mg and 5 mg, the generic version of their Inlyta Tablets, 1 mg and 5 mg. Axitinib is a cancer medicine. It works by blocking the action of the abnormal protein that signals cancer cells to multiply.

Read also: Glenmark gets CDSCO Panel nod to manufacture,market Lobeglitazone, Metformin antidiabetic FDC

Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with a presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology, and oncology. The company has 10 world‐class manufacturing facilities spread across 4 continents and operations in over 80 countries. The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year.

Read also: Glenmark Pharma settles with Pfizer for Axitinib Tablets

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