Quality

At Biocon, excellence through Quality and Compliance is one of our core values and we strive to achieve it consistently across all functions associated with Research & Development, Manufacturing, Testing, Release, and Distribution of our differentiated products.

We follow Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) throughout our operations with no compromise on compliance, which in turn ensures high standards of quality at all times.

A ~1,000 -strong, well-trained Quality team works to monitor every step of the development and manufacturing process to ensure that each and every product manufactured and distributed by us complies with all internationally accepted good practices and standards of quality, purity, efficacy, and safety. Our Quality Control and Quality Assurance teams ensure compliance with cGMPs to deliver high-quality products consistently.

Maintaining Compliance Report

Our manufacturing sites have undergone several regulatory inspections by regulatory authorities across the world as a part of new product approval, and /or verification of compliance. Our strong regulatory, quality and manufacturing capabilities have ensured continued global acceptance of our complex small molecule Active- Pharmaceutical Ingredients and Oral solid dosage formulations and biosimilar products.

Proactive investments in training and certifications; upgradation of quality control and analytical laboratories have helped us maintain a strong compliance track record in regulatory inspections.

Meeting Quality Standards

We are addressing the increasingly demanding benchmarks of stringent global regulatory agencies through our best-in-class technology and processes. Biocon’s manufacturing facilities, located across Bangalore, Hyderabad, Visakhapatnam in India and Johor in Malaysia, have received over 25 cGMP approvals from international regulatory agencies.

Biocon is committed to ensuring the highest level of quality in all of its products and meet the compliance standards expected of a global pharmaceutical company.

FACILITIES APPROVED BY KEY INTERNATIONAL REGULATORY AGENCIES

• U.S. FDA
• Central Drugs Standard
• PMDA, Japan
• Control Organization (CDSCO), India
• ANVISA, Brazil
• NPRA, Ministry of Health, Malaysia
• MCC, South Africa
• EMA
• TGA, Australia
• COFEPRIS, Mexico
• Ministry of Food and Drug Safety (MFDS), South Korea
• Ministry of Health, Russia
• Ministry of Health, Turkey
• Health Canada