Indian pharma cos' new drug filings decline to 20-year low, Nomura says

Abbreviated new drug application filings have declined to 600 in the financial year 2025 (ending in September) versus 740 in the preceding year, Nomura said

Indian pharmaceutical companies' filings for the Abbreviated New Drug Applications (ANDA) declined to a 20-year low in three months to November 2025, Nomura said in its latest observations about the sales and prescription data.

 

Pharmaceutical companies file an ANDA with the US Food and Drug Administration (US FDA) for the review and approval of generic products. After receiving these approvals, companies can make and market generic drugs to provide a lower-cost alternative to the brand-name drug.

 

ANDA filings have declined to 600 in the financial year 2025 (ending at September) versus 740 in the preceding year, Nomura said, citing IQVI data. The decline is showing that the Indian pharma Industry is selective with product development. Almost 17 per cent of the total filings are complex, Nomura noted.

 

Meanwhile, the intensity of new approvals has remained stable in the financial year 2025. The final approval stands at 689 compared to 694 in the previous year. Around 20 per cent of these are first-cycle approvals, Nomura said. 

Pharma sales data trend

Lupin recorded the highest sales in the US market in three months to November 2025, as a new drug launch supported Nomura. Lupin reported that its sales in the US surged 90 per cent Y-o-Y to $488 million during the month on the back of the new launch.  Sales of the generic version of Jynarque tables rose 62 per cent on year to $62 million in three months to November 2025. The company launched the Jynarque drug in May 2025, according to the brokerage.  

 

Cipla is the second one to record the most sales in the US among Indian pharma companies. Its sales rose 55 per cent to $303 million in three months to November, Nomura said, citing IQVIA data.

 

 

Meanwhile, Biocon saw its sales in the US markets declining steeply. The sales declined 59 per cent on year to $305 million in November 2025. Generic Glargine and Generic Pegfilgrastim sales declined due to the recent change in mix between branded and unbranded versions of the product, Nomura said.

 

Dr Reddy’s Laboratories also recorded a sharp decline of 28 per cent Y-o-Y in US sales. The company saw a decline in generic Revlimid on expected lines with no new launches in the recent past. 

 

=====

 

(Disclaimer: The views and investment tips expressed by the brokerage in this article are their own and not those of the website or its management. Business Standard advises users to check with certified experts before taking any investment decisions.)