Amikacin Injectable Solution Generics - Manufacturers & Suppliers
Amikin(Us & EU)
| Product/Composition:- | Amikacin Injectable Solution |
|---|---|
| Strength:- | 250 mg/2 mL, 500 mg/2 mL, 1 g/2 mL |
| Form:- | Injectable Solution |
| Reference Brands:- | Amikin(Us & EU) |
| MOQ | As per the manufacturer batch size |
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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 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.