Topoisomerase Inhibitor
Where is Irinotecan made?
15 companies sell it under their own name. Their labels name 10 factories in India, China, the United States, Germany, France and Taiwan.
India 4China 2United States 1Germany 1France 1Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ipsen Biopharmaceuticals, Inc. Onivyde4.3 mg per 1 mL · NDC 15054-0043 | Hubei Haosun Pharmaceutical Co., Ltd.Makes the active ingredient | Ezhou, China | No problems foundAug 2025 |
| Ipsen Pharma BiotechMakes it, tests it, packages it and labels it | Signes, France | Problems found, fixed voluntarilyMar 2024 | |
| ScinoPharm Taiwan, Ltd.Makes the active ingredient | Tainan, Taiwan | Serious problems, FDA actionJun 2026 | |
| Apotex Corp.20 mg per 1 mL · NDC 60505-6128, 60505-6272 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and labels it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| AuroMedics Pharma LLC20 mg per 1 mL · NDC 55150-352, 55150-353, 55150-354 +1 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| BluePoint Laboratories.20 mg per 1 mL · NDC 68001-480 | Gland Pharma LimitedMakes it and tests it | Visakhapatnam, India | No problems foundJul 2023 |
| Fresenius Kabi, LLC20 mg per 1 mL · NDC 63323-193 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited20 mg per 1 mL · NDC 68083-381, 68083-382 | Gland Pharma LimitedMakes it and tests it | Visakhapatnam, India | No problems foundJul 2023 |
| Hikma Pharmaceuticals USA Inc.20 mg per 1 mL · NDC 0143-9702, 0143-9701, 0143-9583 | Thymoorgan GMBH PharmazieMakes it, tests it, packages it and labels it | Goslar OT Vienenburg, Germany | Problems found, fixed voluntarilyMar 2025 |
| Hospira, Inc.20 mg per 1 mL · NDC 61703-349 | Zydus Hospira Oncology Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2023 |
| Intas Pharmaceuticals20 mg per 1 mL · NDC 59751-087 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Northstar Rx LLC.20 mg per 1 mL · NDC 16714-027, 16714-131 | Gland Pharma LimitedMakes it and tests it | Visakhapatnam, India | No problems foundJul 2023 |
| Pharmacia & Upjohn Company LLC Camptosar20 mg per 1 mL · NDC 0009-7529, 0009-0112, 0009-0082 | Zydus Hospira Oncology Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2023 |
| Qilu Pharmaceutical Co., Ltd.20 mg per 1 mL · NDC 67184-0511, 67184-0512, 67184-0513 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and labels it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| Xiromed, LLC.20 mg per 1 mL · NDC 70700-169, 70700-170 | Gland Pharma LimitedMakes it and tests it | Visakhapatnam, India | No problems foundJul 2023 |
| Actavis Pharma, Inc.20 mg per 1 mL · NDC 45963-614 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Areva Pharmaceuticals, Inc.20 mg per 1 mL · NDC 59923-715, 59923-714, 59923-716 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Nov 19, 2020 · Class II · Areva Pharmaceuticals Inc
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions. - Jun 11, 2020 · Class II · Hikma Pharmaceuticals USA Inc. · 2 recall notices
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. - Sep 23, 2013 · Class II · West-Ward Pharmaceutical Corp. · 2 recall notices
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim. - Jan 22, 2013 · Class II · Fresenius Kabi USA LLC (FK USA)
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.