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'Indian pharma to innovate generics to carve a global niche'
Chronicle Pharmabiz
|September 18, 2025
INDIAN pharma companies are moving away from merely supplying me-too versions of blockbuster drugs. Instead, these companies are increasingly leveraging the US FDA's 505(b)(2) regulatory pathway to create differentiated, value-added generics effectively carving a new global niche, said Dr Hemgir Gosavi, senior manager & centre head - Merck Formulation and Technology Centre, Merck Life Sciences.
The 505(b)(2) applications empower Indian companies to develop branded generics and complex formulations. It offers the room for therapeutic improvements such as better delivery systems or reduced side effects. It is here Merck Formulation and Technology Centre in Mumbai is chipping its support with excipients that form major component of the drug allowing Indian pharma companies to differentiate the existing products without discovering a new molecule, he added.
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