Drug
Who makes busulfan?
9 companies list busulfan as a human prescription drug, including under the names MYLERAN. Forms: injection; injection, solution; injection, solution, concentrate; tablet, film coated. Routes: intravenous, oral.
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 busulfan
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Meitheal Pharmaceuticals, Inc. | injection, solution | ANDAANDA212127 | 2 | 0 |
| Hospira, Inc.United States | injection, solution | ANDAANDA205672 | 1 | 7 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection | ANDAANDA210148 | 1 | 2 |
| Amneal Ireland LimitedIreland | injection | ANDAANDA209580 | 1 | 1 |
| Excella GmbH & Co. KGGermany | tablet, film coated | DRUG FOR FURTHER PROCESSING | 1 | 1 |
| Pharmascience Inc.Canada | injection | ANDAANDA207050 | 1 | 1 |
| Waylis TherapeuticsUnited States | tablet, film coated | NDANDA009386 | 1 | 1 |
| Eugia US LLC | injection, solution | ANDAANDA215102 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution, concentrate | ANDAANDA207050 | 1 | 0 |
Bulk ingredient listings
- Apicore US LLCIndia · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Farmabios S.p.A.Italy · 1 NDC
- PPL Pharma Solutions Riverview LLCUnited States · 1 NDC
- Pacific Medical Industries LtdUnited States · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
Enquiry
Common questions
- Who makes busulfan?
- 9 companies list busulfan as a human prescription drug in the openFDA NDC Directory, led by Meitheal Pharmaceuticals, Inc., Hospira, Inc., ACCORD HEALTHCARE LIMITED, Amneal Ireland Limited, Excella GmbH & Co. KG. 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 MYLERAN?
- 7 companies list busulfan under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies busulfan active ingredient?
- 6 companies list busulfan as a bulk ingredient, including Apicore US LLC, Emcure Pharmaceuticals Limited, Farmabios S.p.A., PPL Pharma Solutions Riverview LLC.