Antiseptic Solutions

Form: Povidone-iodine, Chlorhexidine

Strength: Povidone-iodine typically 10% (w/v), chlorhexidine 0.5%-4% for skin antisepsis and surgical prep

Reference Brands: Betadine (by Purdue Pharma), Chiradex, Hibiclens (by Molnlycke), Peridex (by Colgate)

Category: Medical Devices

Antiseptic solutions such as povidone-iodine and chlorhexidine are regulated in the EU and US to ensure safety, efficacy, and manufacturing quality. In the US, FDA approval requires validation, safety testing, and GMP compliance, while in the EU, CE marking certifies conformity with MDR standards. These products undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring regulatory compliance guarantees access to effective, safe antiseptics critical for infection control in healthcare and veterinary settings worldwide, supporting optimal wound care and surgical safety.