Sun Pharma Drugs Pvt Ltd
🚨 Critical Risk
FEI: 3011116632 • Namli, Sikkim • INDIA
FEI Number
3011116632
Location
Namli, Sikkim
Country
INDIAAddress
107 - 108 Plot, Ranipool, Namli, Sikkim, India
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2025 | 61JDA09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/12/2025 | 54JGA21AMLA (HERBAL & BOTANICALS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 56GCJ99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 61TCA26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2023 | 61NDE81RIVASTIGMINE TARTRATE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2022 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2021 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/30/2020 | 54AGA99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2020 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 61NCB05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2020 | 61ECA04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 65KIY10BIMATOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 65KIY10BIMATOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 61TDF31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2018 | 61NDY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2018 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 62JDA17ROPINIROLE HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2018 | 61TDH31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2018 | 66NCA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 62JCA12CABERGOLINE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 61LCY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 61EDA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2017 | 61NDY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/24/2017 | 66NCA07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 65ACB04MEMANTINE HCI | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62JCB17ROPINIROLE HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 64UDB03CARBIDOPA (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 64UCB99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/28/2016 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/27/2016 | 62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Sun Pharma Drugs Pvt Ltd's FDA import refusal history?
Sun Pharma Drugs Pvt Ltd (FEI: 3011116632) has 42 FDA import refusal record(s) in our database, spanning from 1/27/2016 to 4/25/2025.
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 Drugs Pvt Ltd's FEI number is 3011116632.
What types of violations has Sun Pharma Drugs Pvt Ltd received?
Sun Pharma Drugs Pvt Ltd has been cited for 1 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 Drugs Pvt Ltd come from?
All FDA import refusal data for Sun Pharma Drugs Pvt 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.