GLENMARK PHARMA
⚠️ High Risk
FEI: 3014195583 • Chakala • INDIA
FEI Number
3014195583
Location
Chakala
Country
INDIAAddress
Glenmark House Hdo Corp, , Chakala, , 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 |
|---|---|---|---|
| 7/21/2025 | 62HDY02TOBRAMYCIN (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 61FDY55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 56DYY99AMINOGLYCOSIDES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 56FDY13BACITRACIN ZINC (PEPTIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 65KDY10BIMATOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 54AFY12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 65PDY03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 61PDY68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GLENMARK PHARMA's FDA import refusal history?
GLENMARK PHARMA (FEI: 3014195583) has 10 FDA import refusal record(s) in our database, spanning from 7/21/2025 to 7/21/2025.
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 PHARMA's FEI number is 3014195583.
What types of violations has GLENMARK PHARMA received?
GLENMARK PHARMA 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 PHARMA come from?
All FDA import refusal data for GLENMARK PHARMA 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.