Shares of Alembic Pharmaceuticals rose nearly 11% in Monday morning trade after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its generic cancer drug. As of 10:08 AM, the shares were trading 10.98% higher at Rs 1,075.30.
The approval is for Alembic’s Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection in two strengths: 20 mg/10 mL and 50 mg/25 mL single-dose vials. This generic version is therapeutically equivalent to Doxil Liposome Injection, a product marketed by Baxter Healthcare.
Doxorubicin Hydrochloride Liposome is used in the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.
According to IQVIA data, the approved product has an estimated market size of around $29 million for the 12-month period ending March 2025 in the U.S.
This approval adds to Alembic Pharma’s growing presence in the U.S. generics market. With this, the company’s tally now stands at 224 ANDA approvals, which includes 201 final approvals and 23 tentative approvals.
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