Torrent Pharmaceuticals Ltd
⚠️ High Risk
FEI: 3011567697 • Ahmedabad, Gujarat • INDIA
FEI Number
3011567697
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Ashram Road, , 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 |
|---|---|---|---|
| 2/26/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/11/2025 | 61PCY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/11/2025 | 66NDY04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2025 | 62ODA23CLONIDINE (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 1/14/2025 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 12/12/2024 | 54YEC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2024 | 54YFF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/3/2024 | 60LDY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 64ECY11CHYMOTRYPSIN (ENZYME) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2021 | 61DCA99ANTI-ANGINAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 61NCA85DULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 64BCA37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2021 | 65VDY15DIAZEPAM (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/27/2020 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2020 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2020 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/25/2020 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2019 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2019 | 62OCA44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2018 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/10/2016 | 66MCY03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Torrent Pharmaceuticals Ltd's FDA import refusal history?
Torrent Pharmaceuticals Ltd (FEI: 3011567697) has 22 FDA import refusal record(s) in our database, spanning from 12/10/2016 to 2/26/2025.
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. Torrent Pharmaceuticals Ltd's FEI number is 3011567697.
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.