Imipenem + Cilastatin Iv Generics - Manufacturers & Suppliers
Primaxin, Gemax (US & EU)
| Product/Composition:- | Imipenem + Cilastatin IV |
|---|---|
| Strength:- | 500 mg/500 mg, 1 g/1 g per vial |
| Form:- | Intravenous (IV) Solutions |
| Reference Brands:- | Primaxin, Gemax (US & EU) |
| MOQ | As per the manufacturer batch size |
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Imipenem + Cilastatin inhibits bacterial cell wall synthesis by targeting penicillin-binding proteins, resulting in bacterial lysis. Cilastatin prevents renal degradation of imipenem, prolonging its activity. Benefits include rapid, broad-spectrum action against resistant bacteria, effective in severe infections like pneumonia and sepsis, with reliable bacterial eradication when used appropriately in clinical settings.
Imipenem + Cilastatin intravenous (IV) is approved in both the EU and US for serious bacterial infections, including pneumonia, intra-abdominal, and urinary tract infections. In the EU, brands like Primaxin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical trial data; generic formulations are widely available. Both regions require comprehensive dossiers, including trial results, quality controls, and pharmacovigilance plans, for approval and safety monitoring. For expert support with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate seamless market access ensuring adherence to European and US standards for effective, safe antibacterial therapy.