Glenmark Pharmaceuticals on Wednesday announced that the United States Food & Drug Administration (USFDA) has issued a Form 483 with five procedural observations following a recent inspection at its Monroe, North Carolina manufacturing facility.
The inspection, conducted between June 9 and June 17, 2025, focused on Good Manufacturing Practices (GMP). According to Glenmark’s regulatory filing, all five observations raised by the USFDA were procedural in nature, and importantly, no data integrity issues were identified.
The company has assured that it will work closely with the USFDA to address the noted observations and respond within the stipulated timeline. Glenmark emphasized its commitment to maintaining quality standards and regulatory compliance across its global operations.
The update was disclosed in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
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