Amphotericin B Injectable 50 mg/vial, 50 mg/mL Suppliers & Bulk Manufacturers
Available Forms: Intravenous (IV) Injection
Available Strengths: 50 mg/vial, 50 mg/mL
Reference Brands: Fungizone(EU & US)
Category: Anti-fungal
Amphotericin B binds to fungal cell membrane ergosterol, creating pores that disrupt membrane integrity and cause cell death. It provides broad-spectrum antifungal activity, effective against severe systemic infections. Benefits include potent efficacy, rapid action, and availability in lipid formulations for reduced toxicity, making it essential in managing life-threatening fungal diseases.
Product Description:
Amphotericin B is approved in the EU and US for treating severe systemic fungal infections. In the EU, brands like Fungizone (deoxycholate) and Ambisome (liposomal) are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA-approved formulations include Fungizone and AmBisome, backed by comprehensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with pharmaceutical dossiers, regulatory filings, and compliance, visit PharmaTradz. We facilitate efficient market entry for Amphotericin B formulations, ensuring adherence to European and American standards for safe, effective antifungal therapies.
Amphotericin B Injectable — third party manufacturing & bulk supply
Amphotericin B Injectable 50 mg/vial, 50 mg/mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Amphotericin B Injectable listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Amphotericin B Injectable →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Amphotericin B is used to treat severe and potentially life-threatening systemic fungal infections, including cryptococcosis, mucormycosis, aspergillosis, and systemic candidiasis. It works by binding to ergosterol in fungal cell membranes, creating pores that lead to cell death. It is often used in critically ill or immunocompromised patients.
Amphotericin B is a polyene antifungal compound derived from Streptomyces nodosus. It is formulated with suitable pharmaceutical excipients depending on the presentation, and in its conventional form it is usually complexed with deoxycholate for stability and administration.
Common trade names include Fungizone and Amphocin, used in various global markets.
Fungizone has been manufactured by Bristol-Myers Squibb. Amphocin and other versions have been produced by multiple licensed manufacturers. Many GMP-certified pharmaceutical companies also supply generic amphotericin B worldwide.
The generic name is amphotericin B.
Widely known brand names include Fungizone and Amphocin.
Amphotericin B is manufactured in several GMP-compliant facilities globally, including production sites operated by major pharmaceutical companies in the USA and Europe, as well as multiple approved manufacturers supplying generic amphotericin B to international markets.
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