Sun Pharma Laboratories Ld
⚠️ High Risk
FEI: 3016067500 • East-Sikkim • INDIA
FEI Number
3016067500
Location
East-Sikkim
Country
INDIAAddress
Plot No. 107-108 Mamli Block, P.O. Rainpool, East-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).
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 | 62ODA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/30/2025 | 61WCJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/27/2025 | 62CCA68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/23/2025 | 66TDY03FEBUXOSTAT (XANTHINE OXIDASE INHIBITOR) | Division of Northeast Imports (DNEI) | |
| 10/9/2025 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Division of Southeast Imports (DSEI) | |
| 10/9/2025 | 61DCA02RANOLAZINE (ANTI-ANGINAL) | Division of Southeast Imports (DSEI) | |
| 7/3/2025 | 63OAA06SUMATRIPTAN (ANTIMIGRAINE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2025 | 61NCA74MODAFINIL (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 12/29/2023 | 66NCA06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/20/2021 | 61LCY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2021 | 61NDY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2021 | 66NDY04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/30/2021 | 66BCA99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2021 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2021 | 66BCA99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2021 | 65ACA99MEMORY ADJUVANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2021 | 61NCA74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2020 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 62FDY34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2020 | 62CCY68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2020 | 61NDY74MODAFINIL (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 11/6/2020 | 60SCB99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2020 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2020 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2020 | 65VCY13CLOZAPINE (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2020 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2020 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sun Pharma Laboratories Ld's FDA import refusal history?
Sun Pharma Laboratories Ld (FEI: 3016067500) has 30 FDA import refusal record(s) in our database, spanning from 6/18/2020 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 Ld's FEI number is 3016067500.
What types of violations has Sun Pharma Laboratories Ld received?
Sun Pharma Laboratories Ld 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 Ld come from?
All FDA import refusal data for Sun Pharma Laboratories Ld 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.