Colistin (Polymyxin E)

Form: Injectable (IV/IM/SC)

Strength: 150 mg/5 mL, 300 mg/5 mL, 1.5 million IU/vial

Reference Brands: Coly-Mycin M(US)

Category: Antibiotics

Colistin (Polymyxin E) is approved in the EU and US for severe, multidrug-resistant Gram-negative bacterial infections. In the EU, brands like Colistin 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 safety monitoring. Due to its critical role in combating resistant infections, strict prescribing, storage, and administration regulations are enforced. For regulatory support, dossier preparation, and compliance, visit PharmaTradz. We support seamless market access while ensuring adherence to European and US standards.