Torrent Pharmaceuticals
⚠️ High Risk
FEI: 3009293066 • Gangtok, Sikkim • INDIA
FEI Number
3009293066
Location
Gangtok, Sikkim
Country
INDIAAddress
32 No Middle Camp Nh 31a East, , Gangtok, Sikkim, 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 |
|---|---|---|---|
| 6/26/2025 | 62ODY18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 61LDA43PRASUGREL HYDROCHLORIDE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2024 | 61DCB02RANOLAZINE (ANTI-ANGINAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 63HCA26PRUCALOPRIDE SUCCINATE (CATHARTIC) | Division of Southeast Imports (DSEI) | |
| 11/28/2023 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/26/2023 | 62CCY65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2022 | 63HCY26PRUCALOPRIDE SUCCINATE (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 62CCY65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/14/2021 | 62ODY05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 61PDB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2019 | 61NCA83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2019 | 61NCA83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2018 | 66NDA06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2018 | 66NDA06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2018 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 66MDY03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2016 | 61PCY31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/27/2016 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/29/2015 | 61NCY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/29/2015 | 61NCY37LITHIUM CARBONATE (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/18/2015 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/21/2014 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Torrent Pharmaceuticals's FDA import refusal history?
Torrent Pharmaceuticals (FEI: 3009293066) has 25 FDA import refusal record(s) in our database, spanning from 8/21/2014 to 6/26/2025.
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's FEI number is 3009293066.
What types of violations has Torrent Pharmaceuticals received?
Torrent Pharmaceuticals 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 come from?
All FDA import refusal data for Torrent Pharmaceuticals 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.