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Biocon  /  Businesses  /  Biosimilars  /  Quality & Compliance

BIOCON BIOSIMILARS

Quality & Compliance

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At Biocon Biologics, excellence through Quality and Compliance is one of our core values and we strive to achieve it consistently across all functions associated with Research and 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 without compromising on compliance, to ensure high standards of quality consistently.

Our Quality Control and Quality Assurance teams ensure compliance with cGMPs to deliver high-quality products consistently.

A 1,000 plus-strong, well-trained Quality team monitors every step of the development and manufacturing process to ensure every product complies with 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.

We address 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.

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Facilities Approved By Key International Regulatory Agencies
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U.S. FDA
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EMA
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Central Drugs Standard Control Organisation, India
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PMDA, Japan
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Health Canada
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COFEPRIS, Mexico
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ANVISA, Brazil
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MCC, South Africa
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Ministry of Health, Turkey
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Ministry of Health, Iran
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Ministry of Health, Russia
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NPRA, Ministry of Health, Malaysia
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Ministry of Food and Drug Safety (MFDS), South Korea
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TGA, Australia
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