SUN PHARMA INDUSTRIES LIMITED
⚠️ High Risk
FEI: 3021564517 • Ranipool • INDIA
FEI Number
3021564517
Location
Ranipool
Country
INDIAAddress
Plot No 107/108 Namli B, , Ranipool, , 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 |
|---|---|---|---|
| 7/24/2025 | 62GCL95LOTEPREDNOL ETABONATE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 62TCA07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 7/11/2025 | 61NDA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 6/30/2025 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/12/2025 | 61JDA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2024 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2024 | 64GCY19ETHINYL ESTRADIOL (ESTROGEN) | Division of Southeast Imports (DSEI) | |
| 5/1/2024 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2024 | 62TCB07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 10/24/2022 | 61XDY51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SUN PHARMA INDUSTRIES LIMITED's FDA import refusal history?
SUN PHARMA INDUSTRIES LIMITED (FEI: 3021564517) has 10 FDA import refusal record(s) in our database, spanning from 10/24/2022 to 7/24/2025.
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 INDUSTRIES LIMITED's FEI number is 3021564517.
What types of violations has SUN PHARMA INDUSTRIES LIMITED received?
SUN PHARMA INDUSTRIES LIMITED 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 INDUSTRIES LIMITED come from?
All FDA import refusal data for SUN PHARMA INDUSTRIES 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.