The quality of a drug product relies on the quality of the API. Biocon’s high quality and international Good Manufacturing Practices (GMP) compliance has gained recognition and makes us a trusted partner.
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API
API Strategy
OUR GUIDING PRINCIPLES
Continuous supply reliability through risk mitigation and reliable KSM sourcing
Strong compliance history
“Economies of Scale” to cater to the global demand
With more than two decades of compliance and manufacturing expertise, our API business focuses on long-term reliability. Our partner relationships initiate from product development all the way into its commercial lifecycle. Our value proposition is based on a win-win philosophy and is demonstrated through:
DIFFERENTIATED BUSINESS MODELS
Selective Co-development
Profit share for NCE-1 / First to File launch
Tech-transfers for select products for select geography
Our expertise in fermentation technology, large scale chromatography and synthetic chemistry gives us a key competitive edge in developing new APIs that involve highly complex manufacturing technologies, high potency compounds and complex characterisation requirements.
In addition, Biocon offers pellets / premixes of select APIs basis customer and market requirements, and has a strong development pipeline in the oncology space. This eclectic technology is used to commercialise a unique portfolio of complex APIs and we can cater to global demands through our state-of-the-art manufacturing infrastructure.
Our facilities routinely undergo global accreditations and compliance inspections through various regulatory agencies such as US FDA, EMA, COFEPRIES, ANVISA, PMDA (Japan), NMPS (S. Korea), to supply products to our partners in 100+ countries worldwide.
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CORPORATE GOVERNANCE
