Complex Generics and 505(b)(2) Pathway: The Strategy Generic...

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2025-10-13 11:19:23 -

Complex Generics and 505(b)(2) Pathway: The Strategy Generic Manufacturers are Employing for Higher-Value Injectable Products In the h

In the highly commoditized **Generic Injectables Market**, where price erosion is relentless, manufacturers are increasingly adopting a strategic shift towards **complex generics** and utilizing specialized regulatory pathways, such as the FDA’s 505(b)(2). This strategy is driven by the urgent need to escape the low-margin trap of simple, traditional generics and instead focus on...

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