SYNOKEM PHARMACEUTICALS LTD
⚠️ High Risk
FEI: 3013196003 • UTTARAKHAND • INDIA
FEI Number
3013196003
Location
UTTARAKHAND
Country
INDIAAddress
PLOT 56-57 SECTOR 6A, , UTTARAKHAND, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2025 | 65JCA24NORETHINDRONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2025 | 56ECA60MINOCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2022 | 64GDC07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2021 | 63XCC83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2018 | 64GIA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SYNOKEM PHARMACEUTICALS LTD's FDA import refusal history?
SYNOKEM PHARMACEUTICALS LTD (FEI: 3013196003) has 5 FDA import refusal record(s) in our database, spanning from 12/11/2018 to 12/9/2025.
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. SYNOKEM PHARMACEUTICALS LTD's FEI number is 3013196003.
What types of violations has SYNOKEM PHARMACEUTICALS LTD received?
SYNOKEM PHARMACEUTICALS 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 SYNOKEM PHARMACEUTICALS LTD come from?
All FDA import refusal data for SYNOKEM 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.