Sun Pharma
⚠️ High Risk
FEI: 3008043425 • 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/13/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 65JDA39DROSPIRENONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/16/2025 | 61FCA63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 61BDA02CYPROTERONE ACETATE (ANTI-ANDROGEN) | Division of Southeast Imports (DSEI) | |
| 11/22/2024 | 61ECY08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/1/2024 | 61MDY41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 61NCY69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sun Pharma's FDA import refusal history?
Sun Pharma (FEI: 3008043425) has 10 FDA import refusal record(s) in our database, spanning from 4/30/2018 to 10/24/2025.
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 Pharma's FEI number is 3008043425.
What types of violations has Sun Pharma received?
Sun Pharma has been cited for 2 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 Pharma come from?
All FDA import refusal data for Sun 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.