Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated November 13, 2025, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg.".
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Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for Dexlansoprazole Delayed-Release Capsules in 30 mg and 60 mg strengths. Dexlansoprazole is used to treat gastroesophageal reflux disease (GERD) and related acid reflux conditions. This approval allows Alembic to manufacture and market the generic version of this drug in the US market. The product is commonly known by its brand name Dexilant. This adds to Alembic's growing portfolio of US-approved generic products.
Positive for shareholders — the USFDA approval opens a new revenue stream from US generic sales, though near-term impact depends on market share capture and competition. Likely to support long-term growth in Alembic's US business segment.