Ceftriaxone Injection

Form: Lyophilized powder/ Prefilled syringe

Strength: 250 mg, 1 g, and 2 g

Reference Brands: Rocephin

Category: Active Pharmaceutical Ingredient

Ceftriaxone injectable API 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 clinical validation, safety assessments, and GMP compliance, while in the EU, CE marking certifies conformity with MDR standards. These APIs undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to high-quality ceftriaxone APIs vital for treating systemic bacterial infections worldwide, supporting effective antimicrobial therapy and patient care.