Aminoglycoside Antibacterial
Where is Amikacin made?
9 companies sell it under their own name. Their labels name 6 factories in Austria, India, the United States, Italy, Canada and China.
Austria 1India 1United States 1Italy 1Canada 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Insmed Incorporated Arikayce590 mg per 8.4 mL · NDC 71558-590 | Acs Dobfar SpaMakes the active ingredient | Albano Sant'Alessandro (BG), Italy | Problems found, fixed voluntarilySep 2022 |
| Resilience Biotechnologies, Inc.Makes it and tests it | Mississauga, Canada | Problems found, fixed voluntarilyNov 2023 | |
| Fresenius Kabi, LLC250 mg per 1 mL · NDC 63323-815 | Fresenius Kabi Austria GmbHMakes it, makes the active ingredient and tests it | Linz, Austria | Problems found, fixed voluntarilyMay 2025 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 g per 4 mL, 250 mg per 1 mL, 500 mg per 2 mL · NDC 23155-786, 23155-290, 23155-785 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Hikma Pharmaceuticals USA Inc.250 mg per 1 mL · NDC 0641-6166, 0641-6167 | Hikma Pharmaceuticals USA Inc.Makes it, tests it, packages it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Mullan Pharmaceutical Inc.250 mg per 1 mL · NDC 83301-0022, 83301-0023 | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Makes it | Jinan, China | Problems found, fixed voluntarilyMay 2026 |
| Qilu Pharmaceutical Co., Ltd.250 mg per 1 mL · NDC 67184-0569, 67184-0570 | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Makes it and tests it | Jinan, China | Problems found, fixed voluntarilyMay 2026 |
| Prodigy Innovation, LLC.500 mg · NDC 70297-996 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Safrel Pharmaceuticals, LLC.500 mg · NDC 71309-996 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals250 mg per 1 mL · NDC 25021-173 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- May 21, 2019 · Class I · Heritage Pharmaceuticals, Inc.
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.