Nucleoside Metabolic Inhibitor
Where is Nelarabine made?
14 companies sell it under their own name. Their labels name 8 factories in India, China and Germany.
India 6China 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.5 mg per 1 mL · NDC 62332-813 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Alembic Pharmaceuticals Limited5 mg per 1 mL · NDC 46708-813 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Amneal Pharmaceuticals LLC5 mg per 1 mL · NDC 70121-1743 | Amneal Oncology Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Mahaboobnagar, India | Problems found, fixed voluntarilyOct 2019 |
| Cadila Healthcare Limited5 mg per 1 mL · NDC 70771-1685 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2025 |
| Dr. Reddy's Laboratories Inc.5 mg per 1 mL · NDC 43598-142 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Gland Pharma Limited5 mg per 1 mL · NDC 68083-233 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Visakhapatnam, India | No problems foundJul 2023 |
| Meitheal Pharmaceuticals Inc.5 mg per 1 mL · NDC 71288-165 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Novadoz Pharmaceuticals LLC5 mg per 1 mL · NDC 72205-154 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Shorla Oncology Inc.5 mg per 1 mL · NDC 81927-111, 81927-375 | AqVida GmbHMakes it | Dassow, Germany | Problems found, fixed voluntarilyDec 2024 |
| Zydus Pharmaceuticals (USA) Inc.5 mg per 1 mL · NDC 70710-1726, 70710-1839 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2025 |
| Nexus Pharamaceuticals Inc.5 mg per 1 mL · NDC 14789-114 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals5 mg per 1 mL · NDC 25021-259 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Arranon5 mg per 1 mL · NDC 66758-165 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.5 mg per 1 mL · NDC 39822-0650 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Feb 13, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc · 2 recall notices
Failed Impurities/Degradation Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.