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Alembic Pharmaceuticals Limited ( (IN:APLLTD) ) has issued an announcement.
Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Efinaconazole Topical Solution, 10%, a generic version of Bausch Health Americas Inc.’s Jublia, indicated for the treatment of toenail onychomycosis. The product, for which Alembic was among the first filers with a paragraph IV certification, addresses a US market estimated at about $500 million for the year to December 2025 and lifts Alembic’s cumulative USFDA ANDA approvals to 234, underlining its expanding US generics portfolio and regulatory track record.
More about Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is a vertically integrated research and development-driven pharmaceutical company headquartered in India and publicly listed on domestic exchanges. The company manufactures and markets generic pharmaceutical products globally, is a leader in branded generics in India, and operates state-of-the-art facilities approved by regulators including the USFDA.
Average Trading Volume: 6,305
Technical Sentiment Signal: Sell
Current Market Cap: 152.6B INR
For a thorough assessment of APLLTD stock, go to TipRanks’ Stock Analysis page.