Amikacin Injectable Solution Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 250 mg/2 mL, 500 mg/2 mL, 1 g/2 mL
Reference Brands: Amikin(Us & EU)
Category: Antibiotics
Amikacin Injectable Solution is available in Injectable Solution and strengths such as 250 mg/2 mL, 500 mg/2 mL, 1 g/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 Injectable 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 Injectable 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 IV is approved in the EU and US for serious gram-negative bacterial infections. In the EU, brands like Amikin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data; generic formulations are available. Both regions require detailed dossiers, including clinical trial results, quality assurance, and pharmacovigilance plans for approval and ongoing safety monitoring. Due to its potent antibacterial activity and potential toxicity, strict prescribing controls and monitoring are enforced. For regulatory dossier support, compliance, and registration, visit PharmaTradz. We support seamless market access aligned with European and US standards for safe, 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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