Glenmark receives five procedural observations from USFDA after Monroe facility inspection
By Aditya Bhagchandani Published on June 18, 2025, 09:04 IST
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.
Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.
Ahmedabad Plane Crash
Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
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