Drug
Who makes irinotecan hydrochloride?
14 companies list irinotecan hydrochloride as a human prescription drug, including under the names Camptosar, Onivyde. Forms: injection; injection, powder, for solution; injection, solution. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing irinotecan hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Eugia US LLC | injection, solution | ANDAANDA213278 | 4 | 0 |
| Qilu Pharmaceutical Co., Ltd.China | injection, solution | ANDAANDA203380 | 3 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA091032 | 3 | 4 |
| Pharmacia and Upjohn Company LLC | injection, solution | NDANDA020571 | 3 | 0 |
| Apotex Inc.Canada | injection, solution | ANDAANDA203380 | 2 | 6 |
| Ingenus Pharmaceuticals, LLC | injection | ANDAANDA206935 | 2 | 0 |
| Northstar Rx, LLC, | injection | ANDAANDA212993 | 2 | 0 |
| Hospira, Inc.United States | injection, solution | ANDAANDA077915 | 1 | 7 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA077776 | 1 | 6 |
| GLAND PHARMA LIMITEDIndia | injection | ANDAANDA212993 | 1 | 4 |
| IPSEN MANUFACTURING IRELAND LIMITEDIreland | injection, powder, for solution | NDANDA207793 | 1 | 2 |
| Actavis LLCUnited States | injection, solution | ANDAANDA078589 | 1 | 1 |
| Xiromed LLCIndia | injection | ANDAANDA212993 | 1 | 1 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA090675 | 1 | 0 |
Bulk ingredient listings
- Fermion OyFinland · 1 NDC
- Hubei Haosun Pharmaceutical Co., Ltd.China · 1 NDC
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.China · 1 NDC
- Olon USA LLCItaly · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Shandong Anxin Pharmaceutical Co., Ltd.China · 1 NDC
- Sichuan Xieli Pharmaceutical Co LtdChina · 1 NDC
Orange Book patents
14 unexpired patents list irinotecan hydrochloride as the active ingredient, expiring between Jan 2027 and Oct 2036. Application holder: IPSEN BIOPHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes irinotecan hydrochloride?
- 14 companies list irinotecan hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Eugia US LLC, Qilu Pharmaceutical Co., Ltd., Hikma Pharmaceuticals USA Inc., Pharmacia and Upjohn Company LLC, Apotex Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Camptosar?
- 12 companies list irinotecan hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies irinotecan hydrochloride active ingredient?
- 7 companies list irinotecan hydrochloride as a bulk ingredient, including Fermion Oy, Hubei Haosun Pharmaceutical Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd., Olon USA LLC.