Sun Pharma Sikkim
⚠️ High Risk
FEI: 3007743667 • East Sikkim • INDIA
FEI Number
3007743667
Location
East Sikkim
Country
INDIAAddress
Plot No. 754 Setipool, , 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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2025 | 62JDY09LEVODOPA (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/27/2025 | 62JDY09LEVODOPA (ANTI-PARKINSONIAN) | Division of Southeast Imports (DSEI) | |
| 8/16/2024 | 61FCY63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2024 | 61NCY76PAROXETINE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/22/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2021 | 60SCA99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/1/2021 | 60LAY85MESALAMINE (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 4/21/2021 | 63NDA25URSODIOL (CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2021 | 63HCZ10LACTULOSE (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2021 | 65VCY13CLOZAPINE (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2021 | 62TCY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 60LCY85MESALAMINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2020 | 62GCA99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/8/2020 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2020 | 62JCY12CABERGOLINE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 62JCA99ANTI-PARKINSONIAN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2018 | 61NCA65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2018 | 61MCB30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2018 | 64BCB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2018 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2018 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2018 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2018 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 60XDB02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/25/2017 | 60XDY02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2017 | 61XCA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2016 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/29/2015 | 61NCY69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/17/2015 | 66SDB48ISOSORBIDE MONONITRATE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/14/2014 | 62TCY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/14/2014 | 64PCA04TRANEXAMIC ACID (HEMOSTATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/26/2012 | 65ADA04MEMANTINE HCI | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/12/2009 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sun Pharma Sikkim's FDA import refusal history?
Sun Pharma Sikkim (FEI: 3007743667) has 37 FDA import refusal record(s) in our database, spanning from 11/12/2009 to 6/26/2025.
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 Sikkim's FEI number is 3007743667.
What types of violations has Sun Pharma Sikkim received?
Sun Pharma Sikkim has been cited for 4 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 Sikkim come from?
All FDA import refusal data for Sun Pharma Sikkim 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.