Synokem Pharmaceuticals Ltd
⚠️ High Risk
FEI: 3008583451 • Haridwar • INDIA
FEI Number
3008583451
Location
Haridwar
Country
INDIAAddress
Plot No 35-36 Sector 6a, , Haridwar, , 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
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).
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 |
|---|---|---|---|
| 12/17/2025 | 61JCA16ROSUVASTATIN CALCIUM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 61EDA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Synokem Pharmaceuticals Ltd's FDA import refusal history?
Synokem Pharmaceuticals Ltd (FEI: 3008583451) has 3 FDA import refusal record(s) in our database, spanning from 3/11/2024 to 12/17/2025.
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 3008583451.
What types of violations has Synokem Pharmaceuticals Ltd received?
Synokem Pharmaceuticals 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 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.