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Biocon  /  Businesses  /  Generics  /  Quality & Compliance

QUALITY & COMPLIANCE

QUALITY & COMPLIANCE

Quality & Compliance

At Biocon, excellence is our hallmark and a value and Quality and Compliance enable us to consistently achieve this across all functions of Research & Development, Manufacturing, Testing, Release and Distribution of our differentiated products. We follow Good Manufacturing Practice (GMP), Good Storage Practice (GSP) and Good Distribution Practice (GDP)) throughout our operations to assure high standards of quality.

Over 2000 well-trained Quality professionals monitor our development and manufacturing processes and ensure compliance to cGMPs, to ensure that each and every product complies with all internationally accepted good practices and standards, to assure Quality, Efficacy and Safety.

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MAINTAINING COMPLIANCE
Our manufacturing sites have undergone several regulatory inspections by health authorities across the world as a part of new product approval, and/or verification of compliance. This ensures continued global acceptance of our complex small molecule Active Pharmaceutical Ingredients, Biosimilars and Oral solid dosage formulations.

Proactive investments in infrastructure, training and certifications have helped us maintain a strong compliance track record in regulatory inspections.

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MEETING QUALITY STANDARDS
Our best-in-class technology and processes meet the demanding benchmarks of global regulatory agencies. Our manufacturing facilities across Bengaluru, Telangana and Visakhapatnam in India and Johor in Malaysia, have received over 50 cGMP approvals from international regulatory agencies.
Facilities Approved By Key International Regulatory Agencies
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U.S. FDA
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EMA
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TGA, Australia
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PMDA, Japan
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Health Canada
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MCC, South Africa
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ANVISA, Brazil
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COFEPRIS, Mexico
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Ministry of Food and Drug Safety (MFDS), South Korea
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Ministry of Health, Russia
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NPRA, Ministry of Health, Malaysia
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Ministry of Health, Turkey

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