Glenmark Pharmaceuticals Limited
⚠️ High Risk
FEI: 3008565058 • Dhar, Madhya Pradesh • INDIA
FEI Number
3008565058
Location
Dhar, Madhya Pradesh
Country
INDIAAddress
Plot No 2, Pharma Zone Sez Pithampur; Phase - 2, Dhar, Madhya 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2024 | 61GDY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2019 | 63LDA04SEVELAMER HYDROCHLORIDE (PHOSPHATE BINDER) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/24/2019 | 63LDA04SEVELAMER HYDROCHLORIDE (PHOSPHATE BINDER) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Glenmark Pharmaceuticals Limited's FDA import refusal history?
Glenmark Pharmaceuticals Limited (FEI: 3008565058) has 5 FDA import refusal record(s) in our database, spanning from 1/24/2019 to 11/4/2024.
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 3008565058.
What types of violations has Glenmark Pharmaceuticals Limited received?
Glenmark Pharmaceuticals Limited has been cited for 1 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.