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Time of India
2 days ago
- Business
- Time of India
Alembic Pharmaceuticals gets USFDA nod for generic Carbamazepine tablets
Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic version of Carbamazepine extended-release tablets indicated for treatment of seizures, and relieving nerve pain. The approval by the US Food & Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) of Carbamazepine extended-release tablets of strengths 100 mg, 200 mg, and 400 mg, it said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product Tegretol-XR extended-release tablets in the same strengths, of Novartis Pharmaceuticals Corporation, it added. Alembic said Carbamazepine extended-release tablets are indicated for use as an anticonvulsant drug and also for the treatment of the pain associated with true trigeminal neuralgia. Citing IQVIA data for the 12 months ended March 2025, the company said Carbamazepine extended-release tablets of 100 mg, 200 mg, and 400 mg, have an estimated market size of USD 71 million.
Time of India
30-06-2025
- 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
30-06-2025
- 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.)
Business Standard
30-06-2025
- Business
- Business Standard
Alembic Pharma jumps after receiving USFDA nod for Doxorubicin Hydrochloride Injection
Alembic Pharmaceuticals surged 10.92% to Rs 1,078 after the company received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, of Baxter Healthcare Corporation. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposis sarcoma, and multiple myeloma. According to IQVIA, the estimated market size for Doxorubicin Hydrochloride Liposome Injection single-dose vials is $29 million for the 12 months ending March 2025. Alembic now has a cumulative total of 224 ANDA approvals from the USFDA, including 201 final approvals and 23 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.
Business Upturn
30-06-2025
- Business
- Business Upturn
Alembic Pharma share jump 11% after company gets US FDA approval for Doxorubicin Hydrochloride Injection
Shares of Alembic Pharmaceuticals rose nearly 11% in Monday morning trade after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its generic cancer drug. As of 10:08 AM, the shares were trading 10.98% higher at Rs 1,075.30. The approval is for Alembic's Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection in two strengths: 20 mg/10 mL and 50 mg/25 mL single-dose vials. This generic version is therapeutically equivalent to Doxil Liposome Injection, a product marketed by Baxter Healthcare. Doxorubicin Hydrochloride Liposome is used in the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. According to IQVIA data, the approved product has an estimated market size of around $29 million for the 12-month period ending March 2025 in the U.S. This approval adds to Alembic Pharma's growing presence in the U.S. generics market. With this, the company's tally now stands at 224 ANDA approvals, which includes 201 final approvals and 23 tentative approvals. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
