Amikacin Inhalation Solution 25 mg/2 mL, 50 mg/2 mL Suppliers & Bulk Manufacturers
Available Forms: Inhalation Solution
Available Strengths: 25 mg/2 mL, 50 mg/2 mL
Reference Brands: Amikin(US)
Category: Antibiotics
Amikacin inhalation inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, leading to bacterial cell death. It provides targeted, effective treatment for pulmonary Pseudomonas infections in cystic fibrosis patients. Benefits include rapid bacterial eradication, high local drug concentrations, and reduced systemic toxicity when used as prescribed.
Product Description:
Amikacin inhalation is approved in the EU and US for treating pulmonary infections caused by Pseudomonas aeruginosa in cystic fibrosis patients. In the EU, brands like Amikacin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval relies on extensive clinical data; generic formulations are available. Both regions require detailed dossiers, including clinical trial data, manufacturing standards, and pharmacovigilance plans for approval and continued safety monitoring. Due to its targeted delivery and pulmonary application, strict guidelines on administration are enforced. For expert regulatory support and dossier management, visit PharmaTradz. We ensure seamless market access adhering to EU and US standards for effective antimicrobial therapy.
Amikacin Inhalation Solution — third party manufacturing & bulk supply
Amikacin Inhalation Solution 25 mg/2 mL, 50 mg/2 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 Amikacin Inhalation Solution 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 Amikacin Inhalation Solution →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Amikacin inhalation solution is used for the treatment of lung infections caused by Mycobacterium avium complex (MAC) in adults who have limited or no alternative treatment options. It is primarily used in patients with refractory or treatment-resistant infections as part of combination antibacterial therapy.
It is made from amikacin sulfate, an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis, leading to the death of susceptible bacteria. In inhalation form, it is often formulated as a liposomal suspension to enhance delivery directly to the lungs.
The most well-known trade name is Arikayce (liposomal amikacin for inhalation).
Arikayce is developed and manufactured by Insmed Incorporated. Generic injectable amikacin is produced by multiple companies, but inhalation liposomal formulations are limited to specialized manufacturers.
The generic name is amikacin sulfate inhalation solution (liposomal formulation).
The primary brand name is Arikayce.
It is manufactured in the United States and other regulated facilities by Insmed, with limited global manufacturing due to the specialized liposomal inhalation technology required.
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