Sun Pharma Shares Drop 3.4% After US FDA Flags Dadra Facility

12 Apr 2024 , 03:08 PM

Sun Pharmaceutical Industries witnessed a 3.4% decline in its shares as the US FDA categorized its Dadra facility as ‘official action indicated’ (OAI), suggesting recommended regulatory or administrative actions.

The stock was trading at ₹1,540.10 on the BSE, reflecting a 3.99% decrease from the previous close. Sun Pharma disclosed this classification status in an exchange filing following an inspection conducted from December 4 to 15, 2023.

Recently, the Australian Therapeutic Goods Administration (TGA) approved Winlevi (clascoterone cream 1%), a product of Sun Pharma, for treating acne Vulgaris in patients aged 12 and above. This approval grants Sun Pharma exclusive selling rights in Australia starting June 24 (Q1FY25). Sun Pharma also holds rights to sell Winlevi in the US and Canada since FY22.

Sun Pharma has exclusive development and commercialization rights for Winlevi in the US, Japan, Australia, New Zealand, Brazil, Mexico, and Russia from Cassiopeia SpA. Winlevi is among Sun Pharma’s key products alongside Ilumya, Cequa, Levulan, Absorica, Odomzo, Bromsite, Xelpros, Yonsa, and Sezaby, contributing to the growth of its global specialty sales.

The company has been experiencing steady revenue and net income growth over the last few quarters, driven by strong growth in specialty revenue, which accounts for 19.2% of overall sales as of Q3FY24.

Additionally, Sun Pharma and its subsidiary have entered a licensing agreement with Aclaris Therapeutics, Inc, granting exclusive rights to use Deuruxolitinib, Sun Pharma’s JAK inhibitor, or other forms of Ruxolitinib, for treating alopecia areata.

Sun Pharmaceutical Industries Limited, headquartered in Mumbai, is the largest pharmaceutical company in India and the fourth largest specialty generic pharmaceutical company globally. It manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more than 100 countries across various therapeutic segments.

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