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Indian companies likely to garner up to 50% USFDA nod share in 2023

Companies may get up to 375 ANDA approvals in 2023, more than last year's 355

pharmaceutical sector, pharma sector, medicines, meds

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Photo: Bloomberg

4 min read Last Updated : Dec 15 2023 | 10:30 PM IST

Indian companies are expected to secure a 48–50 per cent share of approvals for new drugs from the US Food and Drug Administration (USFDA) in the 2023 calendar year, similar to the previous year, noted analysts.

According to an analysis by Ashika Research, approximately 762–782 abbreviated new drug approvals (ANDAs) are anticipated globally from the USFDA.

If we estimate that Indian companies hold a 48 per cent share, the number of ANDA approvals for Indian companies is projected to be 365–375 in 2023, slightly more than last year’s figure of around 355.

“To comply with USFDA requirements, companies have focused on strengthening

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