Troikaa Pharmaceuticals Ltd
⚠️ High Risk
FEI: 3008283920 • Ahmedabad, Gujarat • INDIA
FEI Number
3008283920
Location
Ahmedabad, Gujarat
Country
INDIAAddress
1 Commerce House, , Ahmedabad, Gujarat, 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 |
|---|---|---|---|
| 6/30/2025 | 61KDA16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2023 | 61LCY22ANTI-COAGULANT HEPARIN SOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 54BDY20SELENIUM (MINERAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Troikaa Pharmaceuticals Ltd's FDA import refusal history?
Troikaa Pharmaceuticals Ltd (FEI: 3008283920) has 7 FDA import refusal record(s) in our database, spanning from 10/5/2021 to 6/30/2025.
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. Troikaa Pharmaceuticals Ltd's FEI number is 3008283920.
What types of violations has Troikaa Pharmaceuticals Ltd received?
Troikaa 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 Troikaa Pharmaceuticals Ltd come from?
All FDA import refusal data for Troikaa 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.