Lipid-based Polyene Antifungal, Polyene Antifungal
Where is Amphotericin B made?
6 companies sell it under their own name. Their labels name 3 factories in India and Taiwan.
India 2Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| AuroMedics Pharma LLC50 mg per 12.5 mL · NDC 55150-365 | TTY Biopharm Company Limited Lioudu FactoryMakes it, tests it, packages it, labels it and sterilizes it | Keelung City, Taiwan | Problems found, fixed voluntarilyApr 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.50 mg · NDC 62756-954, 62756-233 | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.50 mg · NDC 23155-594 | Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMay 2026 |
| Astellas Pharma US, Inc. AmBisome50 mg per 12.5 mL · NDC 0469-3051 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC50 mg per 12.5 mL · NDC 67457-926 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.50 mg per 10 mL · NDC 39822-1055 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Apr 19, 2024 · Class II · Sun Pharmaceutical Industries Inc
Out of specification for assay - Jun 20, 2013 · Class II · Gilead Sciences, Inc.
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibili… - Jun 19, 2013 · Class II · Astellas Pharma US Inc
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination w…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.