Company
IndiaAlembic Pharmaceuticals Limited (Units I and II), Panchmahal, India – FDA Inspections
Inspection records and compliance data for Alembic Pharmaceuticals Limited (Units I and II) in Panchmahal. 9 FDA inspections on record, 1 Form 483, last inspected May 31, 2025.
Company Profile
This profile covers Alembic Pharmaceuticals Limited (Units I and II) based in Panchmahal, India.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 6, 2011. Last inspected May 31, 2025.
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 31, 2025 | Not classified | Human Drugs | 1270216 |
| October 8, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1249881 |
| December 19, 2018 | Not classified | Human Drugs | 1076862 |
| April 23, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1055013 |
| June 29, 2016 | NAI | Human Drugs · Drug Quality Assurance | 982077 |
| April 18, 2013 | VAI | Human Drugs · Drug Quality Assurance | 831397 |
| April 12, 2013 | VAI | Human Drugs · Drug Quality Assurance | 831337 |
| April 13, 2011 | NAI | Human Drugs · Drug Quality Assurance | 726141 |
| April 6, 2011 | VAI | Human Drugs · Drug Quality Assurance | 725644 |
FDA documents
Form 483s (1)
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Company Information
Name
Alembic Pharmaceuticals Limited (Units I and II)
FEI Number
3003821360
Address
Api Division, Village Panelav P O Tajpura, Near Baska, Taluka Halol, Panchmahal, India
Country
India
ID: 68fd4724-f974-4ddc-8882-a5d28dc90916