Buprenorphine Buccal Film

Form: Buccal film (placed inside the cheek for rapid absorption)

Strength: 75 µg, 150 µg, 300 µg, and 450 µg

Reference Brands: Belbuca

Category: Buccal Films/ Sublingual films

Buprenorphine buccal film is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP standards. In the US, FDA approval involved extensive clinical validation, safety assessments, and GMP compliance, while in the EU, CE marking certifies conformity with MDR standards. These products undergo validation, stability testing, and audits, with detailed documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective buprenorphine buccal films supporting opioid dependence treatment and chronic pain management worldwide, promoting safe, regulated opioid therapies.