Alembic Gets USFDA Nod for Cancer Drug in Single-Dose Vials

Alembic Pharmaceuticals Limited has received final approval of the U.S. Food and Drug Administration (USFDA) on its generic Doxorubicin Hydrochloride Liposome Injection (10 mg/5 mL, 20 mg/10 mL and 50 mg/25 mL) in single dose ampoule.

The drug is a therapeutical equivalent of the Doxil Liposome Injection manufactured by the Baxter healthcare Corporation. It is used in combination with bortezomib and dexamethasone to treat multiple myeloma, AIDS-related Kaposi sarcoma and ovarian cancer. Doxorubicin Hydrochloride Liposome Injection is an anthracycline-inhibitor topoisomerase of the medication intended to act against cancerous cells with lower cardiotoxicity.

The approved product was estimated to be USD 105 million in 2024 in the United States during the previous twelve months ending March. The source of these data is IQVIA. In FY25, Alembic has now got 46 final ANDA approvals (Abbreviated New Drug Applications) by USFDA.

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It is a strategic milestone of Alembic in reinforcing brand oncology portfolio and increasing capacity in the U.S. injectables market. The format of single-dose vials increases the safety and accuracy of dosing in compliance with the demands of the hospital and the clinical setting.

This recent clearance denotes the continued planning in high-value complex generics by Alembic in the regulated markets where sterile injectables and oncology therapeutics is increasingly becoming a focus.