What It Takes to Build an FDA-Approved Oncology Plant in India
India’s pharmaceutical industry has earned its place as the world’s largest supplier of generic medicines, with over 650 manufacturing facilities approved by the US FDA. This number positions India as the global custodian in generics. While this statistic is often cited to highlight scale, a more telling sign of maturity is the rising number of oncology plants built in India, not just to serve domestic markets but to meet the stringent regulatory standards of the US and EU. Among all drug categories, oncology manufacturing demands the most rigorous quality controls, cleanroom architecture, and data integrity systems. Building such a facility isn’t a matter of scaling up what already exists. It’s a fundamental shift in how a company thinks, plans, executes, and sustains compliance.The diffe...










