Imipenem + Cilastatin Powder for Reconstitution

Form: Powder for Reconstitution

Strength: 500 mg/500 mg, 1 g/1 g in vials

Reference Brands: Primaxin, Gemax (US & EU)

Category: Antibiotics

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.