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Glenmark Pharmaceuticals Receives EIR from US FDA for Monroe Facility

Glenmark Pharmaceuticals Receives EIR from US FDA for Monroe Facility

Glenmark Pharmaceuticals announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its formulations manufacturing facility in Monroe, North Carolina (USA) with a Voluntary Action Indicated (VAI) status.

The inspection was conducted at the company’s manufacturing facility from 09 June to 17 June, 2025.

With this positive development, the company will restart commercial manufacturing at the Monroe site.

 
Read more on:
Establishment Inspection Report (EIR) Formulations manufacturing facility Glenmark Monroe Pharma manufacturing Voluntary Action Indicated (VAI) status
More news about: quality / gmp | Published by Dineshwori | November - 27 - 2025 | 170

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