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Biocon  /  Businesses  /  Generics  /  Quality & Compliance

QUALITY & COMPLIANCE

Quality & Compliance

At Biocon, excellence is our hallmark and a value. Quality and Compliance enable us to consistently achieve this throughout the product lifecycle. We follow Good Manufacturing Practices, Good Laboratory Practices, Good Documentation Practices, and Good Distribution Practices throughout our operations to assure high standards of quality and compliance.

Over 850+ highly skilled Quality professionals oversee our development and manufacturing processes, ensuring strict adherence to current Good Manufacturing Practices (cGMPs). Their relentless focus guarantees that every product meets internationally recognized standards of Quality, Efficacy, and Safety, upholding our commitment to global compliance and patient well-being

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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, Hyderabad, Visakhapatnam in India, and Johor in Malaysia have received over 125+ cGMP approvals from international regulatory agencies. Biocon has a new manufacturing facility in Cranbury, New Jersey, US, which was inaugurated in September 2025.
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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