United States Food & Drug Administration (USFDA) has concluded GMP inspection at Glenmark Pharmaceuticals’ manufacturing facility situated in Monroe, North Carolina, USA. The inspection was conducted from June 09 to June 17, 2025.
At the end of the inspection, the Company was issued a Form 483 with five observations. All the observations are procedural in nature. There was no observation related to data integrity reported. The Company will work in close collaboration with the agency to address the observations and will respond to the USFDA within the stipulated timeline.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
| Company Name | CMP |
|---|---|
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| Cipla | 1233.35 |
| Zydus Lifesciences | 938.70 |
| Lupin | 2326.55 |
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