Archive · 18 Jun 2025
Glenmark Pharma Receives USFDA Observations, Gains DCGI Approval
The US government checked a Glenmark Pharma factory in North Carolina and found a few things that needed improvement.
This is like a regular checkup.
They reported five small issues, but nothing about the important data was wrong.
The company will tell the government how they'll fix them.
Also, Glenmark got approval for a new cancer medicine, which could help patients.
USFDA concluded inspection of Glenmark Pharma's North Carolina facility.
The inspection took place from June 9-17, 2025.
USFDA issued a Form 483 with five observations.
Observations were procedural in nature, with no data integrity issues.
Glenmark also received DCGI approval for a cancer medicine.
- Who
- USFDA inspected Glenmark Pharmaceuticals Ltd.
- What
- USFDA issued a Form 483 with five observations.
- When
- The inspection occurred from June 9-17, 2025.
- Where
- Monroe, North Carolina, USA.
- Why
- To ensure compliance with regulations.
Glenmark's Perspective
USFDA's Perspective
Response to Observations
Glenmark's Perspective
Company will work to address the observations.
USFDA's Perspective
N/A
- Company
- Glenmark Pharmaceuticals Ltd
- Facility Location
- Monroe, North Carolina, USA
- Inspection Dates
- June 9-17, 2025
- Observations
- Five
- Data Integrity
- No issues
- Stock Movement
- 0.42 percent higher
- Cancer Medicine
- Zanubrutinib
