Torrent Pharmaceuticals Limited
⚠️ High Risk
FEI: 3005029956 • Indrad, Gujarat • INDIA
FEI Number
3005029956
Location
Indrad, Gujarat
Country
INDIAAddress
Ahmedabad Mehsana Highway,Taluka-Kadi, Dist. Mehsana, , Indrad, 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 |
|---|---|---|---|
| 10/27/2023 | 62ODY40LISINOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2021 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2021 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2020 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2020 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2016 | 61TCE31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/5/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/17/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/23/2015 | 66VIB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2015 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/21/2015 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/8/2014 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/24/2014 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/12/2013 | 61PCA31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/12/2013 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/26/2012 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/17/2012 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/7/2011 | 64BCP48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2011 | 62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/22/2009 | 61TCA99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/19/2009 | 61PCA56REPAGLINIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2009 | 61TCA99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/5/2007 | 66MCY03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/26/2005 | 62GCP18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/18/2005 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/1/2004 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/16/2004 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Torrent Pharmaceuticals Limited's FDA import refusal history?
Torrent Pharmaceuticals Limited (FEI: 3005029956) has 27 FDA import refusal record(s) in our database, spanning from 8/16/2004 to 10/27/2023.
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 Limited's FEI number is 3005029956.
What types of violations has Torrent Pharmaceuticals Limited received?
Torrent Pharmaceuticals Limited 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 Limited come from?
All FDA import refusal data for Torrent Pharmaceuticals Limited 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.