Latest news with #DoxorubicinHydrochlorideLiposome
Time of India
3 days ago
- Business
- Time of India
Alembic Pharmaceuticals gets USFDA nod for generic cancer treatment injection
Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement. 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, it added. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like A planta que tem chamado atenção de quem sofre com refluxo Saúde e Bem Estar Undo Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian Cancer, AIDS-Related Kaposi's sarcoma , and multiple myeloma , the company said. Citing IQVIA data, Alembic said 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 USD 29 million for the 12 months ended March 2025.
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Business Standard
3 days ago
- Business
- Business Standard
Alembic Pharma gets USFDA nod for generic cancer treatment injection
Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement. 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, it added. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian Cancer, AIDS-Related Kaposi's sarcoma, and multiple myeloma, the company said. Citing IQVIA data, Alembic said 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 the 12 months ended March 2025. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
New Indian Express
3 days ago
- Business
- New Indian Express
Alembic Pharma stock jumps 12% on US nod for its generic cancer drug
CHENNAI: Shares of Vadodara-based drug maker Alembic Pharmaceuticals jumped over 12% after the company received approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome injection. This drug is used in cancer treatment and is part of a high-value and competitive segment in the US pharmaceutical market. The approval marks another important step in Alembic's efforts to expand its US generics portfolio. One of India's pioneering pharma companies, Alembic has been steadily building its presence in the US market, with more than 180 Abbreviated New Drug Applications (ANDAs) filed and over 120 already approved. This latest approval is expected to add to its revenue stream and improve market visibility, especially in the oncology segment. The company, which was previously focused mainly on the domestic market through its active pharmaceutical ingredient (API) and formulation businesses—primarily in antibiotics—has only recently begun actively expanding into international markets.
