Drugmaker Glenmark Pharma Receives Establishment Inspection Report From US Health Regulator For Formulations Manufacturing Facility In North Carolina

Drugmaker Glenmark Pharmaceuticals received an establishment inspection report from the US health regulator for formulation manufacturing facility at Monroe, North Carolina, classifying facility as a voluntary action indicated.Under Voluntary Action Indicated, objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action.

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PTI Updated: Thursday, November 27, 2025, 02:28 PM IST
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New Delhi: 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.

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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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Published on: Thursday, November 27, 2025, 02:28 PM IST

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