Imipenem + Cilastatin Powder For Reconstitution Suppliers & Bulk Manufacturers
Available Forms: Powder for Reconstitution
Available Strengths: 500 mg/500 mg, 1 g/1 g in vials
Reference Brands: Primaxin, Gemax (US & EU)
Category:
Antibiotics
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 available in Powder for Reconstitution
and strengths such as 500 mg/500 mg, 1 g/1 g in vials.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Imipenem + Cilastatin Powder for Reconstitution is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Imipenem + Cilastatin Powder for Reconstitution can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
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.
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