Liposomal Bupivacaine

Form: Liposomal injectable solution

Strength: 133 mg/20 mL (6.6 mg/mL)

Reference Brands: EXPAREL

Category: Liposomal Drug Delivery

Liposomal bupivacaine (EXPAREL) is regulated in the EU and US with dossiers demonstrating safety, efficacy, and manufacturing quality aligned with GMP standards. In the US, FDA approval involved extensive clinical validation, safety assessments, and GMP compliance. In the EU, CE marking certifies conformity with MDR standards for regional anesthesia. These formulations undergo validation, stability testing, and audits, supported by comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective extended-release local anesthetic solutions, supporting postoperative pain management worldwide and improving patient outcomes.