Company
IndiaGlenmark Pharmaceuticals Ltd, Pithampur, India – FDA Inspections
Inspection records and compliance data for Glenmark Pharmaceuticals Ltd in Pithampur. 9 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected February 14, 2025.
Company Profile
This profile covers Glenmark Pharmaceuticals Ltd based in Pithampur, India.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 3
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected October 25, 2013. Last inspected February 14, 2025.
Most cited issue areas
- Computer control of master formula records2 inspections
- Investigations of discrepancies, failures2 inspections
- Test methods2 inspections
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1260403 |
| February 25, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1122868 |
| September 13, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1107098 |
| May 24, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1053034 |
| August 26, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1028538 |
| July 8, 2017 | Not classified | Human Drugs | 1020770 |
| February 26, 2016 | VAI | Human Drugs · Drug Quality Assurance | 962557 |
| July 24, 2015 | VAI | Human Drugs · Drug Quality Assurance | 935717 |
| October 25, 2013 | NAI | Human Drugs · Drug Quality Assurance | 854874 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Glenmark Pharmaceuticals Ltd
FEI Number
3008565058
Address
Plot No 2, Phase - 2 Pharma Zone Sez, Pithampur, India
Country
India
ID: 1e6c03ca-7a68-4506-9af3-70d64338538a