Gentamicin Iv Generics - Manufacturers & Suppliers
Garamycin, Bramycin(US)
| Product/Composition:- | Gentamicin IV |
|---|---|
| Strength:- | 40 mg/mL, 80 mg/mL, 80 mg/2 mL, 160 mg/2 mL |
| Form:- | Injectable (IV, IM) |
| Reference Brands:- | Garamycin, Bramycin(US) |
| MOQ | As per the manufacturer batch size |
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Gentamicin IV inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, causing faulty protein production and bacterial death. It provides rapid, broad-spectrum activity against serious gram-negative infections like sepsis and meningitis. Benefits include quick bacterial clearance, effective hospital use, and reliable coverage of multidrug-resistant bacteria when used properly.
Gentamicin IV is approved in both the EU and US for serious bacterial infections, including sepsis and pneumonia. In the EU, brands like Garamycin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data, with generics widely available. Both regions require detailed dossiers, including clinical trial results, manufacturing practices, and pharmacovigilance plans, for approval and ongoing safety monitoring. Due to its potent activity and potential toxicity, strict prescribing and monitoring are enforced. For expert support with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate effective market access aligned with European and US standards.