Intas Pharmaceuticals Ltd
⚠️ High Risk
FEI: 3013501434 • South Sikkim, Namthang Elaka • INDIA
FEI Number
3013501434
Location
South Sikkim, Namthang Elaka
Country
INDIAAddress
Samardung Road, Kabrey Block,, South Sikkim, Namthang Elaka, 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 |
|---|---|---|---|
| 12/1/2025 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2025 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2025 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 61MDY35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/4/2025 | 62TCA07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 5/29/2025 | 61LCY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2024 | 65PDY03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/1/2023 | 61NDB73MIRTAZAPINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/1/2023 | 61NDB73MIRTAZAPINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2021 | 61NCA11CLOMIPRAMINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2021 | 65CDB99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2021 | 62OAA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/18/2021 | 61NCY85DULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2020 | 61MCA35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Intas Pharmaceuticals Ltd's FDA import refusal history?
Intas Pharmaceuticals Ltd (FEI: 3013501434) has 16 FDA import refusal record(s) in our database, spanning from 4/28/2020 to 12/1/2025.
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. Intas Pharmaceuticals Ltd's FEI number is 3013501434.
What types of violations has Intas Pharmaceuticals Ltd received?
Intas Pharmaceuticals 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 Intas Pharmaceuticals Ltd come from?
All FDA import refusal data for Intas Pharmaceuticals 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.