Alembic Pharma Shares Surge Over 10% on USFDA Final Approval for Doxorubicin Hydrochloride Liposome Injection

Mumbai, June 29, 2025 – Alembic Pharmaceuticals Limited (NSE: APLLTD) witnessed a significant surge in its share price today, climbing 10.5% to ₹1070.2, following the announcement of a crucial regulatory milestone. The company confirmed it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection.

The approval covers two key strengths: 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. This generic version is therapeutically equivalent to the reference listed drug product, Doxil Liposome Injection, manufactured by Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection is a vital medication indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi’s Sarcoma, and Multiple Myeloma. According to IQVIA, the estimated market size for this product was approximately US$29 million for the twelve months ending March 2025, highlighting the commercial potential for Alembic Pharmaceuticals.

This latest approval adds to Alembic’s robust portfolio of USFDA-approved products. The company now boasts a cumulative total of 224 ANDA approvals, comprising 201 final approvals and 23 tentative approvals, underscoring its strong presence and capabilities in the highly regulated US pharmaceutical market.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been a prominent player in the healthcare sector since 1907. Headquartered in India, the publicly listed company is known for manufacturing and marketing generic pharmaceutical products globally, with state-of-the-art facilities approved by major regulatory authorities, including the USFDA.

source: Corporate Announcement

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