Drug
Who makes amikacin sulfate?
6 companies list amikacin sulfate as a human prescription drug. Forms: injection; injection, solution. Routes: intramuscular, 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 amikacin sulfate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection, solution | ANDAANDA204040 | 3 | 1 |
| Qilu Pharmaceutical Co., Ltd.China | injection, solution | ANDAANDA218146 | 2 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA063315 | 2 | 4 |
| Mullan Pharmaceutical Inc. | injection | ANDAANDA218146 | 2 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA205604 | 1 | 6 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA203323 | 1 | 0 |
Bulk ingredient listings
- ACS Dobfar S.p.A.Italy · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Shandong Anxin Pharmaceutical Co., Ltd.China · 1 NDC
- Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.China · 1 NDC
Orange Book patents
14 unexpired patents list amikacin sulfate as the active ingredient, expiring between Dec 2026 and May 2035. Application holder: INSMED INC.
Enquiry
Common questions
- Who makes amikacin sulfate?
- 6 companies list amikacin sulfate as a human prescription drug in the openFDA NDC Directory, led by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Qilu Pharmaceutical Co., Ltd., Hikma Pharmaceuticals USA Inc., Mullan Pharmaceutical Inc., Fresenius Kabi USA, LLC. 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 amikacin sulfate?
- 6 companies list amikacin sulfate 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 amikacin sulfate active ingredient?
- 6 companies list amikacin sulfate as a bulk ingredient, including ACS Dobfar S.p.A., Kalchem International Inc., LETCO MEDICAL, LLC, Professional Compounding Centers of America dba PCCA.