Quality & Compliance

Quality and compliance drive our mission to make life-saving biosimilars accessible and affordable to patients, worldwide. Through rigorous practices and a dedication to excellence, we ensure that our biosimilars meet global standards, bringing critical therapies to those who need them most.

The safety of patients treated with our biosimilars is our top priority. We ensure our products are effective treatment therapies, while posing the lowest possible risk to patients. That’s why we are committed to global standards of quality and compliance, with procedures and protocols in line with the following internationally recognized practices:

Good Manufacturing Practices


Good Documentation Practices


Good Storage Practices

Good Clinical Practices


Good Distribution Practices


Good Pharmacovigilance Practices


By leveraging operational, technological and digital excellence, we strive to enhance manufacturing efficiencies, for high-quality product outputs. Regular self-inspections, carried out by site-specific quality teams, supplement our efforts.

Biocon Biologics' Manufacturing Facilities have Received Approvals from Regulatory Authorities Across the Globe

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