What's Happening?
Santosh Kesarpu is recognized for his expertise in complex generic formulation, addressing unmet therapeutic needs through advanced formulation engineering. His work focuses on developing generics for central nervous system therapies, particularly extended-release
systems and formulations with narrow therapeutic windows. Kesarpu applies Quality by Design principles and multivariate statistical approaches to ensure consistent performance and minimize batch failures. His achievements include developing ADHD generics using Multi-Unit Particulate Systems and ion-exchange delivery platforms, improving patient access and mitigating market shortages.
Why It's Important?
Kesarpu's work in complex generic drug development is crucial for addressing national shortages and improving access to essential medications. By applying rigorous scientific and regulatory strategies, he ensures the quality and reliability of generic formulations, benefiting patients and healthcare systems. His focus on patient-centric design and scalable manufacturing processes supports public health goals by enhancing drug availability and affordability. Kesarpu's leadership exemplifies the integration of formulation science and regulatory strategy to solve therapeutic challenges and advance pharmaceutical development.












