Indian Pharma ANDA Filings Analyzed

Indian drug companies are filing fewer plans to make cheaper versions of medicines (called ANDAs) than usual. Between August and November 2025, they submitted 600 ANDA plans, which is a 20-year low according to Nomura, a financial research company. These plans are reviewed by the US Food and Drug Administration (FDA) to make sure the generic versions are safe and work the same way as the original, brand-name drugs.

Key Points

• ANDA filings dropped to 600 in FY2025 (ending Sept).
• Fewer complex medicines are being developed (17% of filings).
• New drug approvals stayed steady with 689 approvals.
• Lupin’s US sales jumped 90% due to a new drug launch.
• Cipla’s US sales increased by 55%, showing strong performance.
• Biocon’s US sales fell significantly due to product mix changes.

The reason for this drop is that companies are being more careful about which medicines they want to make. Almost 1 in 5 ANDA plans are very complicated, so they’re choosing not to tackle them. The number of times the FDA quickly approved new generic drugs (called “first-cycle approvals”) stayed about the same – 20% of the plans got approved quickly.

Some companies are doing really well. Lupin saw a big increase in sales thanks to a new medicine they launched. Their US sales went up 90% in three months! Cipla also saw a big rise in sales in the US, up 55%.

However, some companies aren’t doing so well. Biocon’s sales in the US dropped sharply because of changes in how their medicines are sold. Dr Reddy’s sales also decreased, mainly due to a lack of new drugs they launched.

Understanding these trends in ANDA filings is crucial for predicting the future of affordable medicines in the US market.