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

The facility was inspected from June 9–17, 2025, and the positive outcome clears the way for Glenmark to resume commercial manufacturing at the site.

“This is a key milestone for us, and we are ready to restart operations immediately,” the company said in a statement.