Sun Pharmaceutical Industries Ltd
⚠️ High Risk
FEI: 3011460203 • Mumbai, Maharashtra • INDIA
FEI Number
3011460203
Location
Mumbai, Maharashtra
Country
INDIAAddress
B/1 Sun House Cts No 201, Western India Industrial Estate, Mumbai, Maharashtra, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2025 | 61PCY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 62LDY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 62GCK89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 64DCY99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2023 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2023 | 56CDY64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2021 | 62KCA99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2020 | 56ICA77RIFAMYCIN SODIUM (MACROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 62VDY42VALACYCLOVIR HCL (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 65PCA03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries Ltd's FDA import refusal history?
Sun Pharmaceutical Industries Ltd (FEI: 3011460203) has 20 FDA import refusal record(s) in our database, spanning from 12/17/2015 to 11/3/2025.
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. Sun Pharmaceutical Industries Ltd's FEI number is 3011460203.
What types of violations has Sun Pharmaceutical Industries Ltd received?
Sun Pharmaceutical Industries Ltd has been cited for 1 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 Sun Pharmaceutical Industries Ltd come from?
All FDA import refusal data for Sun Pharmaceutical Industries 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.