Alembic Pharmaceuticals Limited has informed the Exchange regarding 'Alembic Pharmaceuticals receives USFDA Final Approval for Doxorubicin Hydrochloride Liposome Injection'.
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Alembic Pharmaceuticals has received final approval from the USFDA for its generic Doxorubicin Hydrochloride Liposome Injection in two strengths: 20 mg/10 mL and 50 mg/25 mL single-dose vials. The drug is a generic equivalent of Baxter's Doxil and is used to treat ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. The addressable US market for this product is estimated at around US$ 29 million (12 months ending March 2025, per IQVIA). This adds to Alembic's cumulative tally of 224 ANDA approvals (201 final, 23 tentative) from the USFDA, strengthening its US generic portfolio.
Positive for the stock in the short term as it expands Alembic's US product basket with a niche oncology product. The $29M market opportunity is modest but adds to recurring US revenue; actual contribution will depend on Alembic's ability to capture market share post-launch.