Metrochem API Private Limited

DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the

Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutica