The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, of Baxter Healthcare Corporation. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.
According to IQVIA, the estimated market size for Doxorubicin Hydrochloride Liposome Injection single-dose vials is $29 million for the 12 months ending March 2025. Alembic now has a cumulative total of 224 ANDA approvals from the USFDA, including 201 final approvals and 23 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.
The company’s consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.