Alembic Pharmaceuticals Ltd announces USFDA Final Approval for 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma. Refer label for a detailed indication.

Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) Single-Dose Vials have an estimated market size of US$ 29 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 224 ANDA approvals (201 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 971.85 as compared to the previous close of Rs. 974.05. The total number of shares traded during the day was 3761 in over 737 trades.

The stock hit an intraday high of Rs. 989.40 and intraday low of 963.75. The net turnover during the day was Rs. 3680748.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA MultipleMyeloma DoxorubicinHydrochlorideLiposomeInjection OvarianCancer KaposisSarcoma