Alembic Pharmaceuticals 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. 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 $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.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
| Company Name | CMP |
|---|---|
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| Cipla | 1238.25 |
| Zydus Lifesciences | 942.95 |
| Lupin | 2333.90 |
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