Apotex Pharmachem India Pvt Ltd.
⚠️ Moderate Risk
FEI: 3005466325 • Bangalore, Karnataka • INDIA
FEI Number
3005466325
Location
Bangalore, Karnataka
Country
INDIAAddress
Plot 1a Bommasandra Industrial Area 4th Phase, Jigani Link Road, Bommasandra Ind. Estate, Bangalore, 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).
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 |
|---|---|---|---|
| 9/17/2014 | 61QCA05TOLTERODINE TARTRATE (ANTI-DIURETIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/17/2014 | 60LCA90ZOLMITRIPTAN (ANALGESIC) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/17/2014 | 62ODC28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 9/17/2014 | 62ODC28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 7/28/2010 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/28/2010 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/28/2010 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/28/2010 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/28/2010 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/28/2010 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/28/2010 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/28/2010 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Apotex Pharmachem India Pvt Ltd.'s FDA import refusal history?
Apotex Pharmachem India Pvt Ltd. (FEI: 3005466325) has 12 FDA import refusal record(s) in our database, spanning from 7/28/2010 to 9/17/2014.
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 Pharmachem India Pvt Ltd.'s FEI number is 3005466325.
What types of violations has Apotex Pharmachem India Pvt Ltd. received?
Apotex Pharmachem India Pvt Ltd. 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 Apotex Pharmachem India Pvt Ltd. come from?
All FDA import refusal data for Apotex Pharmachem India Pvt 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.