Emcure Pharmaceuticals Limited
🚨 Critical Risk
FEI: 3005151215 • Pune, Maharashtra • INDIA
FEI
FEI Number
3005151215
📍
Location
Pune, Maharashtra
🇮🇳
Country
INDIA🏢
Address
Plot No P2, Midc Hinjawadi; Itbt Park, Pune, Maharashtra, India
Critical Risk
FDA Import Risk Assessment
85.1
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
173
Total Refusals
3
Unique Violations
7/22/2025
Latest Refusal
3/7/2014
Earliest Refusal
Score Breakdown
Violation Severity
80.2×40%
Refusal Volume
83.0×30%
Recency
90.6×20%
Frequency
100.0×10%
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
27167×
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).
756×
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).
1181×
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 |
|---|---|---|---|
| 7/22/2025 | 64PCA02ETHAMSYLATE (HEMOSTATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 61XDY51LEVOCETIRIZINE DIHYDROCHLORIDE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/26/2024 | 66BDY47ARMODAFINIL (STIMULANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 62VDY32LAMIVUDINE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 62VDY53REYATAZ | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 61TDY20TRIMETHOBENZAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/19/2024 | 61TDY20TRIMETHOBENZAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/16/2024 | 62VDA53REYATAZ | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/12/2024 | 60SCY27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/15/2024 | 62GDA48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Division of Southeast Imports (DSEI) | |
| 6/12/2023 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/7/2023 | 64PCA04TRANEXAMIC ACID (HEMOSTATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/4/2023 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/27/2023 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 61JAY99ANTI-CHOLESTEREMIC, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 61MAY99ANTI-CONVULSANT, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 61HAY99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 61NAY66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 61XAY99ANTI-HISTAMINIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 61PAY99ANTI-DIABETIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/24/2023 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/22/2023 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/22/2023 | 61HAY99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/22/2023 | 61HAY99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/22/2023 | 60SAY99ANTACID, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/22/2023 | 61NAY66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/21/2022 | 61JDY03DEXTROTHYROXINE SODIUM (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/29/2022 | 64BDA25HYDROCHLOROTHIAZIDE (DIURETIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/7/2022 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/3/2021 | 64PCA04TRANEXAMIC ACID (HEMOSTATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 62VCA53REYATAZ | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2016 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 60XCA20NADOLOL (ANTI-ADRENERGIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 60XCA20NADOLOL (ANTI-ADRENERGIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62ODA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62ODA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62ODA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62ODA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62ODA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62ODA39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 60SDA25RANITIDINE HYDROCHLORIDE (ANTACID) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 60SDA25RANITIDINE HYDROCHLORIDE (ANTACID) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 60SDA25RANITIDINE HYDROCHLORIDE (ANTACID) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 61XDA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 61XDA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 61XDA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 60SDA25RANITIDINE HYDROCHLORIDE (ANTACID) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 60SDA25RANITIDINE HYDROCHLORIDE (ANTACID) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/17/2016 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 64BCA09BUMETANIDE (DIURETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 61PDA11GLYBURIDE (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 61PDA11GLYBURIDE (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 60SDA25RANITIDINE HYDROCHLORIDE (ANTACID) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 3/16/2016 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Emcure Pharmaceuticals Limited's FDA import refusal history?
Emcure Pharmaceuticals Limited (FEI: 3005151215) has 173 FDA import refusal record(s) in our database, spanning from 3/7/2014 to 7/22/2025.
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. Emcure Pharmaceuticals Limited's FEI number is 3005151215.
What types of violations has Emcure Pharmaceuticals Limited received?
Emcure Pharmaceuticals Limited 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 Emcure Pharmaceuticals Limited come from?
All FDA import refusal data for Emcure 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.