Ajanta Pharma Limited
⚠️ High Risk
FEI: 3001751909 • Mumbai 400 067 • INDIA
FEI Number
3001751909
Location
Mumbai 400 067
Country
INDIAAddress
Ajanta House, 98 Govt. Industrial Area, , Charkop, Kandivli, Mumbai 400 067, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2022 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2022 | 61XCL99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2022 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2021 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2021 | 62OCB43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2021 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2018 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 65PBY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/22/2017 | 65PAY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2016 | 60SDL99ANTACID, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/9/2012 | 60LCA93FROVA | New York District Office (NYK-DO) | |
| 5/9/2012 | 62VCA48VALGANCICLOVIR (ANTI-VIRAL) | New York District Office (NYK-DO) | |
| 10/13/2011 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/7/2009 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/18/2003 | 65PCB02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ajanta Pharma Limited's FDA import refusal history?
Ajanta Pharma Limited (FEI: 3001751909) has 15 FDA import refusal record(s) in our database, spanning from 9/18/2003 to 11/9/2022.
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. Ajanta Pharma Limited's FEI number is 3001751909.
What types of violations has Ajanta Pharma Limited received?
Ajanta Pharma Limited 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 Ajanta Pharma Limited come from?
All FDA import refusal data for Ajanta Pharma 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.