Zydus Cadila Healthcare Ltd
⚠️ High Risk
FEI: 3003369663 • Ahmedabad, Gujarat • INDIA
FEI Number
3003369663
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Zydus Tower, Cross Roads, Opp. Iscon Temple, Satellite, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2025 | 60SCY27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/19/2025 | 62CBO11CLOPAMIDE (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 63BDY30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/30/2024 | 62ODA24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2023 | 60LBY01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 3/3/2023 | 60LDB99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 56PCY01LINEZOLID (OXAZOLIDINONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/20/2021 | 64LCY19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 61TBY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2017 | 65JDY31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/26/2014 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 8/26/2014 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 8/26/2014 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 6/20/2012 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2011 | 62TIS06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | New Orleans District Office (NOL-DO) | |
| 1/5/2011 | 61BCB04BICALUTAMIDE (ANTI-ANDROGEN) | New Orleans District Office (NOL-DO) | |
| 1/5/2011 | 61MCB40TOPIRAMATE (ANTI-CONVULSANT) | New Orleans District Office (NOL-DO) | |
| 1/5/2011 | 61MCB40TOPIRAMATE (ANTI-CONVULSANT) | New Orleans District Office (NOL-DO) | |
| 1/4/2011 | 61MIB30VALPROATE SODIUM (ANTI-CONVULSANT) | New Orleans District Office (NOL-DO) | |
| 1/6/2009 | 61NIS99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/8/2006 | 62GAA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/8/2006 | 56YYK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/23/2006 | 62OIY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/1/2006 | 62OCS22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/14/2005 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/10/2005 | 60LAB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/6/2004 | 65FAK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Zydus Cadila Healthcare Ltd's FDA import refusal history?
Zydus Cadila Healthcare Ltd (FEI: 3003369663) has 29 FDA import refusal record(s) in our database, spanning from 12/6/2004 to 12/17/2025.
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. Zydus Cadila Healthcare Ltd's FEI number is 3003369663.
What types of violations has Zydus Cadila Healthcare Ltd received?
Zydus Cadila Healthcare Ltd has been cited for 4 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 Zydus Cadila Healthcare Ltd come from?
All FDA import refusal data for Zydus Cadila Healthcare 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.