Drug
Who makes melphalan hydrochloride?
13 companies list melphalan hydrochloride as a human prescription drug. Forms: 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 melphalan hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Dr. Reddy's Laboratories LimitedIndia | kit | ANDAANDA203655 | 2 | 15 |
| Fresenius Kabi USA, LLCUnited States | kit | ANDAANDA203393 | 1 | 6 |
| Qilu Pharmaceutical Co., Ltd.China | kit | ANDAANDA211463 | 1 | 5 |
| GLAND PHARMA LIMITEDIndia | kit | ANDAANDA209826 | 1 | 4 |
| BPI Labs, DBA Ally LabsUnited States | kit | ANDAANDA209197 | 1 | 2 |
| Camber Pharmaceuticals, Inc.United States | kit | ANDAANDA215024 | 1 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | kit | ANDAANDA206523 | 1 | 1 |
| Arthur Group LLC | kit | ANDAANDA211463 | 1 | 0 |
| Avenacy, Inc. | kit | ANDAANDA211463 | 1 | 0 |
| Fosun Pharma USA Inc. | kit | ANDAANDA209826 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | kit | ANDAANDA212960 | 1 | 0 |
| Mylan Institutional Inc. | kit | ANDAANDA090270 | 1 | 0 |
| Sagent Pharmaceuticals | kit | ANDAANDA209826 | 1 | 0 |
Bulk ingredient listings
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Farmabios S.p.A.Italy · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
- Zhejiang ChemPacific Corporation · 1 NDC
Orange Book patents
18 unexpired patents list melphalan hydrochloride as the active ingredient, expiring between Mar 2029 and Jun 2036. Application holders: ACROTECH BIOPHARMA INC, APOTEX INC, DELCATH SYSTEMS INC.
Enquiry
Common questions
- Who makes melphalan hydrochloride?
- 13 companies list melphalan hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Dr. Reddy's Laboratories Limited, Fresenius Kabi USA, LLC, Qilu Pharmaceutical Co., Ltd., GLAND PHARMA LIMITED, BPI Labs, DBA Ally Labs. 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 melphalan hydrochloride?
- 13 companies list melphalan hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies melphalan hydrochloride active ingredient?
- 10 companies list melphalan hydrochloride as a bulk ingredient, including APOTHECON PHARMACEUTICALS PRIVATE LIMITED, Aurobindo Pharma Limited, Emcure Pharmaceuticals Limited, Farmabios S.p.A..