Drug
Who makes bendamustine hydrochloride?
11 companies list bendamustine hydrochloride as a human prescription drug, including under the names BELRAPZO, Bendeka, TREANDA, VIVIMUSTA. Forms: injection; injection, powder, lyophilized, 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 bendamustine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection, powder, lyophilized, for solution | ANDAANDA205574 | 2 | 2 |
| Cephalon, Inc. | injection, powder, lyophilized, for solution | NDANDA022249 | 2 | 0 |
| Eugia US LLC | injection, powder, lyophilized, for solution | ANDAANDA214739 | 2 | 0 |
| Baxter Healthcare CorporationUnited States | injection | NDANDA216078 | 1 | 16 |
| Apotex Inc.Canada | injection, solution | NDANDA215033 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | injection, solution | NDANDA208194 | 1 | 6 |
| Eagle Pharmaceuticals, Inc.United States | injection | NDANDA205580 | 1 | 5 |
| Avyxa GmbHSwitzerland | injection | NDANDA219014 | 1 | 1 |
| Azurity Pharmaceuticals, Inc. | injection | NDANDA212209 | 1 | 0 |
| BluePoint Laboratories Inc. | injection, powder, lyophilized, for solution | ANDAANDA205574 | 1 | 0 |
| Slayback Pharma LLC | injection | NDANDA212209 | 1 | 0 |
Bulk ingredient listings
- Chongqing Huapont Pharmaceutical Co LtdChina · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- NATCO PHARMA LIMITEDIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
Orange Book patents
35 unexpired patents list bendamustine hydrochloride as the active ingredient, expiring between Mar 2029 and Jul 2042. Application holders: AZURITY PHARMACEUTICALS INC, CEPHALON INC, EAGLE PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes bendamustine hydrochloride?
- 11 companies list bendamustine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by ACCORD HEALTHCARE LIMITED, Cephalon, Inc., Eugia US LLC, Baxter Healthcare Corporation, 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 BELRAPZO?
- 3 companies list bendamustine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 8 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies bendamustine hydrochloride active ingredient?
- 9 companies list bendamustine hydrochloride as a bulk ingredient, including Chongqing Huapont Pharmaceutical Co Ltd, Dr. Reddy's Laboratories Limited, Emcure Pharmaceuticals Limited, MSN Laboratories Private Limited,.