Amikacin Inhalation Solution 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. Amikacin Inhalation Solution is available in Inhalation Solution and strengths such as 25 mg/2 mL, 50 mg/2 mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Amikacin Inhalation Solution is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Amikacin Inhalation Solution can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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