MANIKAND PHARMA LTD
⚠️ High Risk
FEI: 3015261998 • South Sikkim, Sikkim • INDIA
FEI Number
3015261998
Location
South Sikkim, Sikkim
Country
INDIAAddress
Doring Block Bermiok El, , South Sikkim, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2026 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2025 | 62VCA69ACYCLOVIR; HYDROCORTISONE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2025 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2024 | 61WDY45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2024 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2024 | 54AFY10MECOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2024 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MANIKAND PHARMA LTD's FDA import refusal history?
MANIKAND PHARMA LTD (FEI: 3015261998) has 7 FDA import refusal record(s) in our database, spanning from 6/17/2024 to 1/14/2026.
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. MANIKAND PHARMA LTD's FEI number is 3015261998.
What types of violations has MANIKAND PHARMA LTD received?
MANIKAND PHARMA LTD 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 MANIKAND PHARMA LTD come from?
All FDA import refusal data for MANIKAND PHARMA 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.