GLENMARK PHARMACEUTICALS LIMITED
⚠️ Moderate Risk
FEI: 3012777038 • Mumbai, Maharashtra • INDIA
FEI Number
3012777038
Location
Mumbai, Maharashtra
Country
INDIAAddress
Glenmark House, 3rd Fl; Link Road, 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).
Refusal History
Frequently Asked Questions
What is GLENMARK PHARMACEUTICALS LIMITED's FDA import refusal history?
GLENMARK PHARMACEUTICALS LIMITED (FEI: 3012777038) has 3 FDA import refusal record(s) in our database, spanning from 6/3/2020 to 4/17/2023.
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 3012777038.
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.