Drug
Who makes mitomycin?
12 companies list mitomycin as a human prescription drug, including under the names JELMYTO, Mitosol, ZUSDURI, MUTAMYCIN. Forms: injection, powder, lyophilized, for solution; kit. 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 mitomycin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| BluePoint Laboratories Inc. | injection, powder, lyophilized, for solution | ANDAANDA064144, ANDA216732 | 6 | 0 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection, powder, lyophilized, for solution | ANDAANDA064144 | 5 | 2 |
| Hikma Pharmaceuticals USA Inc.United States | injection, powder, lyophilized, for solution | ANDAANDA064117 | 4 | 4 |
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA215687, ANDA216648 | 3 | 6 |
| GLAND PHARMA LIMITEDIndia | injection, powder, lyophilized, for solution | ANDAANDA215687, ANDA216648 | 3 | 4 |
| Archis Pharma LLC | injection, powder, lyophilized, for solution | ANDAANDA202670, ANDA203386 | 3 | 0 |
| Eugia US LLC | injection, powder, lyophilized, for solution | ANDAANDA216732 | 3 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution | ANDAANDA214504, ANDA214505 | 3 | 0 |
| Sagent Pharmaceuticals | injection, powder, lyophilized, for solution | ANDAANDA215687, ANDA216648 | 3 | 0 |
| Bryant Ranch PrepackUnited States | injection, powder, lyophilized, for solution | ANDAANDA202670 | 2 | 1 |
| UroGen Pharma, Inc. | kit | NDANDA211728, NDA215793 | 2 | 0 |
| Mobius Therapeutics LLC | kit | NDANDA022572 | 1 | 0 |
Bulk ingredient listings
- Concord Biotech LimitedIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Hubei Honch Pharamceutical Co., Ltd. · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Qingdao Biopeptek Co LtdChina · 1 NDC
- Sicor S.r.l. · 1 NDC
- Wuxi Fortune Pharmaceutical Co., Ltd.China · 1 NDC
- Zhejiang Hisun Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
8 unexpired patents list mitomycin as the active ingredient, expiring between Jan 2028 and Jan 2031. Application holders: GLAUKOS CORP, UROGEN PHARMA LTD.
Enquiry
Common questions
- Who makes mitomycin?
- 12 companies list mitomycin as a human prescription drug in the openFDA NDC Directory, led by BluePoint Laboratories Inc., ACCORD HEALTHCARE LIMITED, Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC, GLAND PHARMA LIMITED. 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 JELMYTO?
- 10 companies list mitomycin 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 mitomycin active ingredient?
- 9 companies list mitomycin as a bulk ingredient, including Concord Biotech Limited, Darmerica, LLC, Hubei Honch Pharamceutical Co., Ltd., MEDISCA Inc..