SUN PHARMCEUTICALS LTD
⚠️ High Risk
FEI: 3015206068 • Namli, Sikkim • INDIA
FEI Number
3015206068
Location
Namli, Sikkim
Country
INDIAAddress
Plot No 107 - 108, Ranipool, Namli, Sikkim, 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
Frequently Asked Questions
What is SUN PHARMCEUTICALS LTD's FDA import refusal history?
SUN PHARMCEUTICALS LTD (FEI: 3015206068) has 2 FDA import refusal record(s) in our database, spanning from 9/19/2023 to 5/12/2025.
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. SUN PHARMCEUTICALS LTD's FEI number is 3015206068.
What types of violations has SUN PHARMCEUTICALS LTD received?
SUN PHARMCEUTICALS LTD 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 SUN PHARMCEUTICALS LTD come from?
All FDA import refusal data for SUN PHARMCEUTICALS 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.