Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated October 29, 2025, titled "Alembic Pharmaceuticals Limited announces USFDA Final Approval for Ticagrelor Tablets, 60 mg".
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Alembic Pharmaceuticals has received final approval from the USFDA (United States Food and Drug Administration) for its generic version of Ticagrelor Tablets in the 60 mg strength. Ticagrelor is an antiplatelet drug commonly prescribed to reduce the risk of heart attack and stroke in patients with acute coronary syndrome. Final approval allows Alembic to manufacture and commercially launch the product in the US market. This adds to Alembic's growing portfolio of US-approved generic products. The approval strengthens the company's presence in the US generic pharmaceuticals segment, which is a key revenue driver.
Positive for shareholders — this approval enables Alembic to tap into the US market for Ticagrelor, potentially adding to US revenue. Short-term stock reaction may be modest given competition in the generic ticagrelor space, but it reinforces the company's USFDA pipeline strength.