Sun Pharma Laboratories Ltd
⚠️ High Risk
FEI: 3014216406 • Dist Kamrup, Assam • INDIA
FEI Number
3014216406
Location
Dist Kamrup, Assam
Country
INDIAAddress
Kokjhar Mirza, Palasbari Road, Dist Kamrup, Assam, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2025 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2025 | 61MCA42LEVETIRACETAM (ANTI-CONVULSANT) | Division of Northeast Imports (DNEI) | |
| 10/18/2024 | 61KDL05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/23/2024 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2024 | 61NCE80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/1/2024 | 61NAY80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 64PCA04TRANEXAMIC ACID (HEMOSTATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2020 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2019 | 62ODA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 56ADY99PENICILLIN NATURAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 61XDY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2018 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sun Pharma Laboratories Ltd's FDA import refusal history?
Sun Pharma Laboratories Ltd (FEI: 3014216406) has 15 FDA import refusal record(s) in our database, spanning from 8/9/2018 to 12/5/2025.
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 Laboratories Ltd's FEI number is 3014216406.
What types of violations has Sun Pharma Laboratories Ltd received?
Sun Pharma Laboratories Ltd has been cited for 3 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 Laboratories Ltd come from?
All FDA import refusal data for Sun Pharma Laboratories 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.