Alembic Pharmaceuticals Gets USFDA Approval for Doxorubicin Injection; Stock Surges

Alembic Pharmaceuticals saw a strong rally in its stock on Monday, rising 13.61% during the session and touching a day’s high of ₹1,104.10. The upmove came after the company achieved a major regulatory breakthrough in the U.S.

The U.S. Food and Drug Administration (USFDA) has granted final approval to Alembic’s Doxorubicin Hydrochloride Liposome Injection, a chemotherapy medication used in cancer treatment. The drug will be sold in two strength variants:

• 20 mg/10 mL (2 mg/mL)
• 50 mg/25 mL (2 mg/mL)

Both forms are single-use vials designed for intravenous delivery. This formulation is prescribed in the treatment of three serious health conditions:

• Ovarian cancer
• Kaposi’s Sarcoma linked to AIDS
• Multiple myeloma, a type of blood-related cancer.

As per data from IQVIA, the U.S. market size for this injectable product stood at approximately $29 million for the 12-month period ending March 2025. The latest approval brings Alembic’s total ANDA (Abbreviated New Drug Application) approvals from the USFDA to 224, including:

• 201 full approvals
• 23 tentative approvals

Alembic Pharmaceuticals shares closed with a 5.17% gain or at ₹1,019 on June 30, 2025. Alembic Pharmaceuticals shares have gained 10% in the last year, dipped 2.8% in the year-to-date, and gained 2.3% in the previous month.

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