Apotex Research Private Limited
⚠️ Moderate Risk
FEI: 3006076314 • Bengaluru, Karnataka • INDIA
FEI Number
3006076314
Location
Bengaluru, Karnataka
Country
INDIAAddress
Plot No.1 And 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Rd, Bengaluru, Karnataka, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
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 |
|---|---|---|---|
| 4/18/2018 | 60LCE83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/18/2018 | 60LCE83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/18/2018 | 60LCE83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/18/2018 | 60LCE83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/13/2018 | 60LCE83CELECOXIB (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 4/13/2018 | 60LCE83CELECOXIB (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 4/13/2018 | 60LCE83CELECOXIB (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 3/31/2015 | 61QCA05TOLTERODINE TARTRATE (ANTI-DIURETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 3/31/2015 | 61QCA05TOLTERODINE TARTRATE (ANTI-DIURETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 3/31/2015 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Apotex Research Private Limited's FDA import refusal history?
Apotex Research Private Limited (FEI: 3006076314) has 10 FDA import refusal record(s) in our database, spanning from 3/31/2015 to 4/18/2018.
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. Apotex Research Private Limited's FEI number is 3006076314.
What types of violations has Apotex Research Private Limited received?
Apotex Research Private Limited 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 Apotex Research Private Limited come from?
All FDA import refusal data for Apotex Research Private 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.