Alkem Laboratories Ltd
⚠️ High Risk
FEI: 3006585372 • Mumbai, Maharashtra • INDIA
FEI Number
3006585372
Location
Mumbai, Maharashtra
Country
INDIAAddress
Senapati Bapat Marglowel Parel, , Mumbai, Maharashtra, 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 |
|---|---|---|---|
| 12/5/2025 | 54AFA14VIT D | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2025 | 56BCC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2025 | 61PDY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2025 | 61PDY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 7/3/2025 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2025 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2025 | 62TDA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2025 | 62CCA41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 61GDK85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 2/27/2024 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 61TDE31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2023 | 60SCB99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2023 | 62TDA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2022 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2021 | 61WCE46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2020 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2020 | 60SDA99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 61TCA26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/6/2019 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2019 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2018 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 61NDA69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 56JCJ20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2018 | 63ACA07RISEDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2017 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/27/2016 | 62TCH07PANTOPRAZOLE SODIUM | New Orleans District Office (NOL-DO) | |
| 1/20/2015 | 56BAB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2010 | 64LCP41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Alkem Laboratories Ltd's FDA import refusal history?
Alkem Laboratories Ltd (FEI: 3006585372) has 38 FDA import refusal record(s) in our database, spanning from 6/2/2010 to 12/5/2025.
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. Alkem Laboratories Ltd's FEI number is 3006585372.
What types of violations has Alkem Laboratories Ltd received?
Alkem Laboratories Ltd 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 Alkem Laboratories Ltd come from?
All FDA import refusal data for Alkem Laboratories 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.