Microtubule Inhibitor
Where is Docetaxel made?
22 companies sell it under their own name. Their labels name 13 factories in India, China, France and Germany.
India 8China 3France 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.20 mg per 1 mL · NDC 16729-231, 16729-267 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Sanofi-Aventis U.S. LLC20 mg per 1 mL, 80 mg per 4 mL, 160 mg per 8 mL · NDC 0955-1022, 0955-1020, 0955-1021 | Sanofi Winthrop IndustrieMakes the active ingredient and tests it | Vitry sur-Seine, France | Problems found, fixed voluntarilyOct 2024 |
| Sanofi-Aventis Deutschland GmbHMakes it, tests it, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 | |
| Zhuhai Beihai Biotech Co., Ltd. Beizray20 mg per 1 mL · NDC 83513-009, 83513-008 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Ningbo Shuangcheng Pharmaceutical Co., LtdMakes it | Ningbo, China | Not inspected on record | |
| Zydus Pharmaceuticals (USA) Inc. Beizray20 mg per 1 mL · NDC 70710-2152, 70710-2092 | Kindos Pharmaceuticals Co., Ltd.Makes it and tests it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Ningbo Shuangcheng Pharmaceutical Co., LtdMakes it and tests it | Ningbo, China | Not inspected on record | |
| Alembic Pharmaceuticals Inc.10 mg per 1 mL · NDC 62332-678 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Alembic Pharmaceuticals Limited10 mg per 1 mL · NDC 46708-678 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| AuroMedics Pharma LLC10 mg per 1 mL · NDC 55150-378, 55150-379, 55150-380 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Baxter Healthcare Corporation10 mg per 1 mL · NDC 43066-001, 43066-006, 43066-010 +3 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.20 mg per 1 mL, 80 mg per 4 mL, 160 mg per 8 mL · NDC 47335-939, 47335-323, 47335-895 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Dr. Reddy's Laboratories Inc.20 mg per 1 mL, 80 mg per 4 mL, 160 mg per 8 mL · NDC 43598-389, 43598-258, 43598-611 +2 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Gland Pharma Limited10 mg per 1 mL · NDC 68083-399, 68083-400, 68083-401 | Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.20 mg per 1 mL, 80 mg per 4 mL, 160 mg per 8 mL · NDC 23155-905, 23155-903, 23155-904 | Sichuan Huiyu Pharmaceutical Co., Ltd.Makes it | Neijiang, China | Not inspected on record |
| Hospira, Inc.10 mg per 1 mL, 20 mg per 1 mL · NDC 0409-2026, 0409-0016, 0409-0201 +8 | Zydus Hospira Oncology Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2023 |
| Actavis Pharma, Inc.20 mg per 1 mL · NDC 45963-734, 45963-765 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals LLC20 mg per 1 mL, 80 mg per 4 mL, 160 mg per 8 mL · NDC 70121-1223, 70121-1221, 70121-1222 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avyxa Pharma, LLC Docivyx20 mg per 2 mL, 80 mg per 8 mL, 160 mg per 16 mL · NDC 83831-103, 83831-101, 83831-102 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.20 mg per 1 mL · NDC 0143-9204, 0143-9205 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Jiangsu Hengrui Pharmaceuticals Co., Ltd.20 mg per 1 mL, 80 mg per 4 mL, 160 mg per 8 mL · NDC 57884-3043, 57884-3041, 57884-3042 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.10 mg per 1 mL, 20 mg per 1 mL, 20 mg per 2 mL · NDC 71288-151, 71288-144, 71288-133 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC10 mg per 1 mL, 20 mg per 1 mL · NDC 72078-086, 72078-040, 72078-087 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals10 mg per 1 mL, 20 mg per 1 mL · NDC 25021-254, 25021-245 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.10 mg per 1 mL · NDC 66758-050 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- May 28, 2024 · Class I · Sagent Pharmaceuticals · 2 recall notices
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. - Mar 6, 2019 · Class II · Dr. Reddy's Laboratories, Inc.
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance. - Apr 27, 2018 · Class II · Sanofi-Aventis U.S. LLC
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed. - Jan 9, 2017 · Class II · Dr. Reddy's Laboratories, Inc.
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.