Glenmark Pharmaceuticals Limited
⚠️ High Risk
FEI: 3008191605 • Solan, Himachal Pradesh • INDIA
FEI Number
3008191605
Location
Solan, Himachal Pradesh
Country
INDIAAddress
Unit 11, Village Bhattanwala, P.o. Pajpura, Solan, Himachal Pradesh, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2025 | 61WDY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2024 | 56DDY41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2024 | 62CDL41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 3/23/2017 | 62FCJ53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61FCY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/28/2016 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/6/2016 | 62JDY13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Glenmark Pharmaceuticals Limited's FDA import refusal history?
Glenmark Pharmaceuticals Limited (FEI: 3008191605) has 8 FDA import refusal record(s) in our database, spanning from 4/6/2016 to 12/2/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Glenmark Pharmaceuticals Limited's FEI number is 3008191605.
What types of violations has Glenmark Pharmaceuticals Limited received?
Glenmark Pharmaceuticals Limited has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Glenmark Pharmaceuticals Limited come from?
All FDA import refusal data for Glenmark Pharmaceuticals Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.