Drug Approval | November 27, 2025
Glenmark Pharma gets VAI from FDA for Monroe facility
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
A total of five observations for Goa and 17 for Monroe
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
The partnership will further strengthen Olympus leadership in the diagnosis and staging of liver disease
Key takeaways of Q3FY22 quarter & conference call highlights
The company reports revenue growth of 26% and PAT growth of 21% YoY
Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina
This marks Glenmark's first synthetic decapeptide injectable approval
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