Mankind Pharma Ltd.
⚠️ High Risk
FEI: 3004993131 • New Delhi, Delhi • INDIA
FEI Number
3004993131
Location
New Delhi, Delhi
Country
INDIAAddress
208, Okhla Industrial Estate Phase-III,, , New Delhi, Delhi, 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).
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 |
|---|---|---|---|
| 12/18/2025 | 56CDA64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/30/2025 | 61JDA16ROSUVASTATIN CALCIUM | Division of Northeast Imports (DNEI) | |
| 8/27/2025 | 61WCJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2025 | 61GCY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 61PDA70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2025 | 61XDL51LEVOCETIRIZINE DIHYDROCHLORIDE | Division of Southeast Imports (DSEI) | |
| 7/11/2025 | 60SDY26SUCRALFATE (ANTACID) | Division of Southeast Imports (DSEI) | |
| 6/30/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 61XCL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 56CCA64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2024 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2024 | 56YYY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/18/2024 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2024 | 63HCA10LACTULOSE (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2024 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2024 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 56DDY40NEOMYCIN (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2024 | 65RCR18SODIUM BICARBONATE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2024 | 56CDA54CEFIXIME (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/13/2023 | 61HDA99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/4/2023 | 62OCB18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2021 | 61WDY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2021 | 65QCY60CYCLOBENZAPRINE HYDROCHLORIDE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2020 | 64ECL99ENZYME N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 62GCB10BROMELAINS (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2016 | 62OCB09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/16/2016 | 61TAE31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/11/2016 | 61JDB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/25/2016 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/17/2015 | 62ODB18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/14/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/17/2014 | 61JCY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/26/2010 | 65JDA38MIFEPRISTONE (PROGESTIN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mankind Pharma Ltd.'s FDA import refusal history?
Mankind Pharma Ltd. (FEI: 3004993131) has 38 FDA import refusal record(s) in our database, spanning from 5/26/2010 to 12/18/2025.
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. Mankind Pharma Ltd.'s FEI number is 3004993131.
What types of violations has Mankind Pharma Ltd. received?
Mankind Pharma Ltd. has been cited for 3 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 Mankind Pharma Ltd. come from?
All FDA import refusal data for Mankind Pharma 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.