Imipenem + Cilastatin Powder For Reconstitution Generics - Manufacturers & Suppliers
Primaxin, Gemax (US & EU)
| Product/Composition:- | Imipenem + Cilastatin Powder for Reconstitution |
|---|---|
| Strength:- | 500 mg/500 mg, 1 g/1 g in vials |
| Form:- | Powder for Reconstitution |
| 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, causing 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, and reliable bacterial eradication when used appropriately in clinical settings.
Imipenem + Cilastatin powder for reconstitution is approved in the EU and US for treating severe bacterial infections such as 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 data; generic formulations are available. Both regions require detailed dossiers, including clinical trial results, manufacturing practices, and pharmacovigilance plans for approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate seamless market access, ensuring adherence to European and US standards for safe, effective antibacterial therapy.