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 (US & EU)

Category: Antibiotics

Imipenem and cilastatin sterile powder in 500 mg/500 mg and 1 g/1 g vials, a carbapenem antibiotic for severe hospital infections. For importers, hospital pharmacies and tender buyers of injectable antibiotics.

Product Description:

This sterile powder combines imipenem, a carbapenem beta-lactam antibiotic, with cilastatin sodium in equal amounts. Imipenem binds penicillin-binding proteins and stops bacteria building their cell wall, killing a very wide range of Gram-positive, Gram-negative and anaerobic bacteria. Cilastatin blocks dehydropeptidase-I, a kidney enzyme that would otherwise break imipenem down. The page lists 500 mg/500 mg and 1 g/1 g vials. Imipenem is not absorbed orally, so it is given by IV infusion after reconstitution.

It is a hospital antibiotic for severe infections, such as complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia, septicaemia and fever in neutropenic patients. WHO's AWaRe system places it in the Watch group, and its use is usually restricted. Infusion runs 20 to 60 minutes by dose, and dosing is reduced in kidney impairment. Seizures are the key risk, mainly with high doses, renal impairment or CNS disease. It sharply lowers valproate levels, so the two are not combined, and severe beta-lactam allergy needs caution.

Sourcing notes. Carbapenems are beta-lactams, so production needs segregated facilities; ask for a GMP certificate covering the sterile beta-lactam line. Ask for the CTD or ACTD dossier with zone IVb stability data for hot humid markets, plus a CoPP. The batch CoA should show assay of both components, related substances, sterility, endotoxins, particulate matter and water. Glass vials are kept dry below 25 °C, with no cold chain. Reconstituted solution lasts only hours at room temperature. It is prescription-only. Give strength, vials per carton and label language in your enquiry.