New Delhi: Regulatory scrutiny in the US has cast a dark cloud on approvals for new drugs from domestic generic biggies in the world’s most lucrative pharma market.
ANDA (abbreviated new drug application) by the USFDA (US Food and Drug Administration) witnessed a subdued first quarter in FY25, with aggregate approvals for major companies falling to the lowest levels in last eight quarters, analysts told TOI.ANDAs are critically important for domestic pharma companies as they provide a pathway to access the US market as well as boost their revenues.
Major companies, including Cipla and Sun Pharma, continued to struggle with regulatory issues and were able to secure only a few approvals, an analyst at BNP Paribas said. New approvals for Aurobindo Pharma fell to the lowest level in the last seven quarters due to regulatory issue at Unit III manufacturing facility of its subsidiary Eugia Pharma.
Major companies like Cipla, Aurobindo, Dr Reddy’s, Lupin and Sun Pharma are facing USFDA scrutiny, ranging from inspections and warning letters over the last year. ANDAs are used to seek approval from the USFDA to market a generic version of an already approved ‘reference’ drug.
The US business for most companies is expected to grow around 2-4% quarter on quarter and around 8% y-o-y, driven by stability in pricing and new launches, a note from ICICI said. The launch of generic Revlimid, a blockbuster cancer drug, is an upside to companies, such as Dr Reddy’s Labs, Zydus, Cipla, Sun Pharma and Aurobindo. Further, Lupin’s revenues received a shot in the arm with generic Sprivia, a key respiratory drug, while generic Mirabegron, a medication to treat an overactive bladder, will also be a growth driver.
Overall revenues of the companies are expected to grow at a modest pace of 9% y-o-y. The India business is likely to grow at a faster pace of 10%, driven by seasonality-led demand for acute products, analysts added.

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