Glenmark Pharmaceuticals Ltd
⚠️ Moderate Risk
FEI: 3004109039 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3004109039
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
A - 607 Glenmark Research Centre, Midc Mahape, Navi Mumbai, Maharashtra, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2016 | 61XCS99ANTI-HISTAMINIC N.E.C. | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 11/24/2009 | 61XCS99ANTI-HISTAMINIC N.E.C. | 223FALSE | Seattle District Office (SEA-DO) |
| 1/15/2009 | 61QIB03DESMOPRESSIN ACETATE (ANTI-DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/3/2008 | 64LIL37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/3/2008 | 64LIL37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Glenmark Pharmaceuticals Ltd's FDA import refusal history?
Glenmark Pharmaceuticals Ltd (FEI: 3004109039) has 5 FDA import refusal record(s) in our database, spanning from 6/3/2008 to 3/16/2016.
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 Ltd's FEI number is 3004109039.
What types of violations has Glenmark Pharmaceuticals Ltd received?
Glenmark Pharmaceuticals Ltd has been cited for 3 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 Ltd come from?
All FDA import refusal data for Glenmark Pharmaceuticals Ltd 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.