Glenmark Pharma North Carolina facility gets USFDA OAI status
Mumbai: Glenmark Pharmaceuticals Limited has recently announced that the company has received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for the company's Monroe, North Carolina (USA) facility.The OAI classification implies inter‐alia that the USFDA may withhold approval of any pending product applications or supplements filed from...
Mumbai: Glenmark Pharmaceuticals Limited has recently announced that the company has received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for the company's Monroe, North Carolina (USA) facility.
The OAI classification implies inter‐alia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.
Monroe facility was inspected from April 04 to May 19, 2022, and received Form‐483 with 17 observations.
Read also: Glenmark Pharma launches Sitagliptin and its FDCs for Type 2 diabetes in India
Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.
Read also: Cipla, Glenmark and 1 other recall products in US over manufacturing issues
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