Glenmark Pharmaceuticals Limited
🚨 Critical Risk
FEI: 3005757050 • Solan, Himachal Pradesh • INDIA
FEI Number
3005757050
Location
Solan, Himachal Pradesh
Country
INDIAAddress
Village Kishanpura, Baddi Nalagarh Road, Baddi, Solan, Himachal Pradesh, India
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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
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).
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 |
|---|---|---|---|
| 12/22/2025 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/5/2025 | 64HDY02GUAIFENESIN (EXPECTORANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/27/2025 | 56GDY99ANTIFUNGAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/27/2025 | 61WCE46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 62FCO53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 65LDA11TITANIUM DIOXIDE (PROTECTANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 62OCH09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 64HDY02GUAIFENESIN (EXPECTORANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/26/2025 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/2/2025 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/8/2025 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 3/4/2025 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/22/2025 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 1/10/2025 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/6/2024 | 62NCA99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2024 | 61WCH46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/2/2024 | 61WCY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/14/2024 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 11/14/2024 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 10/24/2024 | 61WDL04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/8/2024 | 62QDY99ANTI-RHEUMATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/26/2024 | 62FDY53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 62SDY02ADAPALENE (ANTI-SEBORRHEIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/30/2024 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2024 | 62OCY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Northeast Imports (DNEI) | |
| 8/16/2024 | 61WCY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/15/2024 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/10/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/25/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/19/2024 | 61JDA09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/4/2023 | 61PDY26METFORMIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 10/18/2023 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/6/2023 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/3/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/6/2023 | 64HDL02GUAIFENESIN (EXPECTORANT) | Division of Southeast Imports (DSEI) | |
| 1/20/2023 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/19/2023 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/17/2023 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 1/17/2023 | 64HDL99EXPECTORANT N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/9/2023 | 64TDY08TACROLIMUS (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 12/3/2022 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/30/2022 | 64HDL99EXPECTORANT N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 2/19/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2020 | 61HCB99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 64TCJ08TACROLIMUS (IMMUNOSUPPRESSIVE) | Division of Southeast Imports (DSEI) | |
| 7/28/2020 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2020 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 64UAC99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2019 | 62ODH09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2019 | 66RCY01ANGIOTENSIN AMIDE (VASOCONSTRICTOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2018 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2018 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2018 | 62OCB09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2018 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 66SCY46CILOSTAZOL (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2016 | 62OCY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Glenmark Pharmaceuticals Limited's FDA import refusal history?
Glenmark Pharmaceuticals Limited (FEI: 3005757050) has 60 FDA import refusal record(s) in our database, spanning from 9/12/2016 to 12/22/2025.
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. Glenmark Pharmaceuticals Limited's FEI number is 3005757050.
What types of violations has Glenmark Pharmaceuticals Limited received?
Glenmark Pharmaceuticals 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 Glenmark Pharmaceuticals Limited come from?
All FDA import refusal data for Glenmark Pharmaceuticals 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.