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North Carolina

By Gurleen Bajwa , 19 June 2025
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Glenmark Receives USFDA Form 483 with Five Observations at Monroe Facility

Glenmark Pharmaceuticals announced that its Monroe, North Carolina manufacturing plant has received a Form 483 from the United States Food and Drug Administration (USFDA) following a routine inspection. Conducted between June 9 and June 17, 2025, the inspection resulted in five procedural observations, with no findings related to data integrity. Glenmark emphasized its commitment to addressing the issues in a timely manner, in cooperation with the regulatory agency. While the regulatory scrutiny garnered attention, the company’s stock remained stable, edging up 0.22% to close at Rs.

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