Sun Pharmaceutical Industries Limited
⚠️ High Risk
FEI: 3004561553 • Dadra, Dadra & Nagar Haveli and Daman • INDIA
FEI Number
3004561553
Location
Dadra, Dadra & Nagar Haveli and Daman
Country
INDIAAddress
Survey No. 1012, , Dadra, Dadra & Nagar Haveli and Daman, 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 |
|---|---|---|---|
| 9/9/2025 | 60CDY61MIRABEGRON (ADRENERGIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 11/20/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2018 | 62CCA66BOSENTAN | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/7/2018 | 62CCA66BOSENTAN | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/14/2012 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2012 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/3/2009 | 60CDP55DAPIPRAZOLE HYDROCHLORIDE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/27/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/10/2007 | 63EDY99CARDIAC DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/10/2007 | 60LDY99ANALGESIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/5/2007 | 61NCC65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/5/2007 | 61MCC06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries Limited's FDA import refusal history?
Sun Pharmaceutical Industries Limited (FEI: 3004561553) has 12 FDA import refusal record(s) in our database, spanning from 7/5/2007 to 9/9/2025.
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 Pharmaceutical Industries Limited's FEI number is 3004561553.
What types of violations has Sun Pharmaceutical Industries Limited received?
Sun Pharmaceutical Industries Limited 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 Pharmaceutical Industries Limited come from?
All FDA import refusal data for Sun Pharmaceutical 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.