TORRENT PHARMACEUTICALS LTD
⚠️ High Risk
FEI: 3012377509 • Ahmedabad, Gujarat • INDIA
FEI Number
3012377509
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Torrent 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).
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 |
|---|---|---|---|
| 1/12/2026 | 61PDA31GLIMEPIRIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 5/4/2023 | 56BDY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 12/29/2021 | 60XDY17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2021 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2021 | 61MDA99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TORRENT PHARMACEUTICALS LTD's FDA import refusal history?
TORRENT PHARMACEUTICALS LTD (FEI: 3012377509) has 7 FDA import refusal record(s) in our database, spanning from 6/5/2020 to 1/12/2026.
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. TORRENT PHARMACEUTICALS LTD's FEI number is 3012377509.
What types of violations has TORRENT PHARMACEUTICALS LTD received?
TORRENT 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 TORRENT PHARMACEUTICALS LTD come from?
All FDA import refusal data for TORRENT 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.