Glenmark Pharmaceuticals Ltd. has announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practices (GMP) inspection at its manufacturing facility in Monroe, North Carolina, USA.
The inspection, which took place from June 9 to June 17, 2025, concluded with the issuance of a Form 483 containing five observations. According to the company, all the observations are procedural in nature, and notably, there were no issues raised regarding data integrity—an important metric often closely watched by regulators and investors.
In a regulatory filing with the BSE, Glenmark stated that it is committed to addressing all the procedural observations in a timely manner. The company also confirmed that it will work closely with the USFDA to respond within the stipulated timeline.
This development comes as part of routine regulatory oversight by the USFDA, which regularly audits pharmaceutical manufacturing units to ensure compliance with established quality standards.
Investors and industry observers are expected to closely monitor Glenmark’s response and subsequent communication from the USFDA regarding the resolution of these observations.
