Glenmark Monroe Facility Gets USFDA VAI Status
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Glenmark Pharmaceuticals' Monroe facility receives Voluntary Action Indicated (VAI) status from USFDA. Commercial manufacturing to restart.
New Delhi, Nov 27 (PTI) Drugmaker Glenmark Pharmaceuticals Ltd on Thursday said it has received establishment inspection report from the US health regulator for its formulations manufacturing facility at Monroe, North Carolina, classifying the facility as voluntary action indicated.
The inspection was conducted at the company's manufacturing facility from June 9 to June 17, 2025, Glenmark Pharmaceuticals Ltd said in a statement.
With this positive development, the company will restart commercial manufacturing at the Monroe site, it added.
Under Voluntary Action Indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.
The inspection was conducted at the company's manufacturing facility from June 9 to June 17, 2025, Glenmark Pharmaceuticals Ltd said in a statement.
With this positive development, the company will restart commercial manufacturing at the Monroe site, it added.
Under Voluntary Action Indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.
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