Links and Files

• Quality and Compliance in the Pharmaceutical Industry: Navigating a Transformed Landscape

Authors

• Partha Anbil, Prashant Deshpande, and Partha Khot

Abstract

• Generic drugs produced in non-advanced economies exhibit substantially higher serious recall rates, reflecting reverse-engineering limitations and market incentives that underfund quality differentiation.
• Recent cGMP breakdowns and rising FDA warning letters underscore heightened enforcement, with recall-associated sites heavily concentrated in the US and India.

Journal

Pharmaceutical Commerce

Type of publication

Online Magazine

Affiliations

• Coforge Limited

Classification Areas

• Process Modeling, Control, and Data Analytics
• Regulatory