SUN PHARMACEUTICAL INDIA
⚠️ High Risk
FEI: 3015187015 • Solan • INDIA
FEI Number
3015187015
Location
Solan
Country
INDIAAddress
Kh No 1835-1840, Near E, , Solan, , 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/12/2025 | 62GAL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/18/2024 | 62GCL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SUN PHARMACEUTICAL INDIA's FDA import refusal history?
SUN PHARMACEUTICAL INDIA (FEI: 3015187015) has 4 FDA import refusal record(s) in our database, spanning from 11/18/2020 to 6/12/2025.
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 INDIA's FEI number is 3015187015.
What types of violations has SUN PHARMACEUTICAL INDIA received?
SUN PHARMACEUTICAL INDIA 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 SUN PHARMACEUTICAL INDIA come from?
All FDA import refusal data for SUN PHARMACEUTICAL INDIA 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.