Latest news with #DoxilLiposomeInjection
Time of India
a day 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
a day 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.)
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Business Standard
a day ago
- Business
- Business Standard
Why is Alembic Pharmaceuticals' share in demand today? Key details here
Alembic Pharmaceuticals share price: Pharmaceutical major Alembic Pharmaceuticals share price skyrocketed up to 13.98 per cent to hit an intraday high of 1,107.80 per share on Monday, June 30, 2025. Around 12:15 PM, Alembic Pharmaceuticals shares continued to trade near day's high, up 13.34 per cent at 1,101.45 per share. In comparison, BSE Sensex was trading 0.20 per cent lower at 83,892.01 levels. What triggered the rally in Alembic Pharmaceuticals share price today? Alembic Pharmaceuticals' share price surged after the company received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection in two dosage strengths — 20 mg/10 mL and 50 mg/25 mL single-dose vials. The approved product is a therapeutic equivalent of Doxil Liposome Injection by Baxter Healthcare Corporation, and is used in the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. As per IQVIA, the drug has an estimated market size of around $29 million for the 12 months ending March 2025. With this approval, Alembic Pharmaceuticals now holds a total of 224 ANDA approvals from the USFDA, including 201 final and 23 tentative approvals. Alembic Pharmaceuticals Q4 results Alembic Pharmaceuticals reported a 12 per cent year-on-year (Y-o-Y) decline in net profit for the fourth quarter of FY25 (Q4FY25), which stood at ₹157 crore, despite a 17 per cent rise in net sales to ₹1,770 crore. Ebitda grew 9 per cent to ₹286 crore, with the margin at 16 per cent, while profit before tax increased 5 per cent to ₹192 crore. READ MORE About Alembic Pharmaceuticals Alembic Pharmaceuticals is among the leading Indian pharmaceutical companies with a legacy dating back to 1907. Headquartered in Vadodara, Gujarat, the company has built a strong global presence through its vertically integrated operations that span research, development, manufacturing, and marketing of pharmaceutical products. It is publicly listed and is known for its robust pipeline of generic drugs, backed by advanced R&D infrastructure and regulatory approvals from key markets, including the USFDA. With manufacturing units located in Gujarat and Sikkim, and R&D centres across Vadodara, Hyderabad, and New Jersey, Alembic Pharmaceuticals serves both domestic and international markets. Its subsidiaries, Alembic Pharmaceuticals Inc. and Alembic Global Holding SA, further support its global footprint, making it a trusted name in both branded and generic pharmaceuticals worldwide.
Business Standard
a day ago
- 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.
Economic Times
a day ago
- Business
- Economic Times
Alembic Pharma shares rally 12% on USFDA nod for cancer drug
Live Events (You can now subscribe to our (You can now subscribe to our ETMarkets WhatsApp channel Shares of Alembic Pharmaceuticals climbed as much as 12% on Monday to Rs 1,089.80 on BSE after the company received final approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome Injection , a cancer treatment a press release issued Sunday, the company announced that it had received final USFDA approval 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 company noted, '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.'The injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. 'Refer to label for detailed indication,' the company IQVIA data, Alembic estimated the market size of Doxorubicin Hydrochloride Liposome Injection in the U.S. to be $29 million for the twelve months ending March cumulative count of USFDA approvals now stands at 224 ANDAs, comprising 201 final approvals and 23 tentative this month, on June 18, the company also received an Establishment Inspection Report (EIR) from the USFDA for its API-III facility in Karakhadi, following an inspection conducted from March 17 to March 21, stock has been on a steady uptrend. It has gained 22.7% in the past year, 2.5% in the past six months, 15.7% over the last three months, and 6.8% in the past a technical standpoint, the stock is currently trading above all its key simple moving averages (5-day to 200-day), signaling bullish momentum across time frames. The Relative Strength Index (RSI) is at 52.4, indicating neutral territory, while the Moving Average Convergence Divergence (MACD) is at 2.4, staying above its center line though still below its signal stock hit a 52-week high of Rs 1,296.15 on October 9, 2024, and a 52-week low of Rs 725.60 on March 3, 2025.
