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 inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, leading to faulty protein production and bacterial cell death. It provides rapid, broad-spectrum activity against serious gram-negative infections such as sepsis and pneumonia. Benefits include quick bacterial eradication, effective hospital use, and coverage of resistant bacteria when used properly.
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.
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