SUN PHARMA IND LTD
⚠️ High Risk
FEI: 3018026147 • East Sikkim • INDIA
FEI Number
3018026147
Location
East Sikkim
Country
INDIAAddress
Plot No 107 108 Namli B, , 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).
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 |
|---|---|---|---|
| 3/25/2025 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2025 | 61MCA06CLONAZEPAM (ANTI-CONVULSANT) | Division of Southeast Imports (DSEI) | |
| 3/19/2025 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2025 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2024 | 64XCY11ISOTRETINOIN (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 12/6/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2024 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 62OCY43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 62TCY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2024 | 66BCA47ARMODAFINIL (STIMULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 61MCE99ANTI-CONVULSANT, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/29/2024 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2024 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/16/2024 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/30/2023 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2023 | 62TDB07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2022 | 65PDA99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 62TDA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2021 | 61NCB67FLUVOXAMINE MALEATE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 9/13/2021 | 62JCA15PRAMIPEXOLE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2021 | 61NCA85DULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2021 | 62OCA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/21/2021 | 62CCA68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SUN PHARMA IND LTD's FDA import refusal history?
SUN PHARMA IND LTD (FEI: 3018026147) has 26 FDA import refusal record(s) in our database, spanning from 6/21/2021 to 3/25/2025.
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 IND LTD's FEI number is 3018026147.
What types of violations has SUN PHARMA IND LTD received?
SUN PHARMA IND LTD 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 IND LTD come from?
All FDA import refusal data for SUN PHARMA IND 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.