Glenmark Pharmaceuticals LTD
⚠️ High Risk
FEI: 3005466252 • Mumbai 400 026 • INDIA
FEI Number
3005466252
Location
Mumbai 400 026
Country
INDIAAddress
B/2, Mahalakshmi Chambers, 22, Bhulabhai Desai Road, Mumbai 400 026, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2024 | 62GCR99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/23/2021 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 61WBY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/18/2019 | 61GAJ82MUPIROCIN CALCIUM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/21/2018 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2017 | 61WCA46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/28/2016 | 63BCA99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/12/2016 | 56GAY99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2016 | 62KDB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/1/2012 | 65CDJ04BETAINE ANHYDROUS (NUTRIENT/TONIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/1/2012 | 62CDJ41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/12/2007 | 62FCJ53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/22/2006 | 61MCS99ANTI-CONVULSANT, N.E.C. | New York District Office (NYK-DO) | |
| 10/14/2004 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/5/2004 | 60LCB01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Glenmark Pharmaceuticals LTD's FDA import refusal history?
Glenmark Pharmaceuticals LTD (FEI: 3005466252) has 16 FDA import refusal record(s) in our database, spanning from 8/5/2004 to 1/12/2024.
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. Glenmark Pharmaceuticals LTD's FEI number is 3005466252.
What types of violations has Glenmark Pharmaceuticals LTD received?
Glenmark Pharmaceuticals LTD 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 Glenmark Pharmaceuticals LTD come from?
All FDA import refusal data for Glenmark Pharmaceuticals 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.