Paracetamol (Acetaminophen) Injection

Form: Injectable solution

Strength: 1000 mg/100 mL (10 mg/mL)

Reference Brands: Ofirmev

Category: Analgesic

Paracetamol (acetaminophen) injection is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involves validation, safety testing, and clinical validation, while in the EU, CE marking certifies conformity with MDR standards. These formulations undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring regulatory compliance guarantees access to safe, effective paracetamol IV formulations, vital for managing acute pain and fever, especially when oral administration is not feasible worldwide.