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The Hindu
24-04-2025
- Business
- The Hindu
Aurobindo Pharma arm gets U.S. FDA nod for generic of BMS' cancer drug
Aurobindo Pharma subsidiary Eugia Pharma Specialities has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Dasatinib Tablets in different strengths. Bioequivalent and therapeutically equivalent to the reference listed drug Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), the product is expected to be launched by June. The approved product has an estimated market size of $1.8 billion for the twelve months ending February 2025, Aurobindo said, citing IQVIA MAT numbers. Dasatinib Tablets is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia in chronic phase; adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy; and adults with Ph+ acute lymphoblastic leukaemia with resistance or intolerance to prior therapy, the company said. This is the 181st ANDA approval, including nine tentative approvals received, out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Time of India
23-04-2025
- Business
- Time of India
Aurobindo Pharma arm gets USFDA nod for generic blood cancer drug
Aurobindo Pharma on Wednesday said its wholly- owned arm Eugia Pharma Specialities Ltd has received final approval from the USFDA to manufacture and market its generic version of Dasatinib tablets indicated in certain types of cancer of bone marrow and blood. The approval by the US Food & Drug Administration (USFDA) is for manufacturing and marketing of Dasatinib tablets of strengths 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Aurobindo Pharma said in a regulatory filing. These are bioequivalent and therapeutically equivalent to the reference listed drug Sprycel Tablets in the same strengths, of Bristol-Myers Squibb Company (BMS), it added. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like If You Eat Ginger Everyday for 1 Month This is What Happens Tips and Tricks Undo The product is expected to be launched in Q1FY26, Aurobindo Pharma said. The approved product has an estimated market size of USD 1.8 billion for the 12 months ended February 2025, it said citing IQVIA MAT data.
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Business Standard
23-04-2025
- Business
- Business Standard
Aurobindo Pharma in focus: Why has the stock gained 3% in trade today?
Aurobindo Pharma Ltd share price: Shares of Aurobindo Pharma gained 2.9 per cent in trade, registering an intraday high at ₹1,222.9 on the BSE. The up move in the stock came after the company arm Eugia Pharma Specialities, received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Dasatinib tablets. According to the filing, Dasatinib tablets are indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib and adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. At 12:22 PM, Aurobindo Pharma shares were trading 2.65 per cent higher at ₹1,219.6 per share on the BSE. In comparison, the BSE Sensex was up 0.20 per cent at 79,757.46. The market capitalisation of the company stood at ₹70,834.57 crore. The 52-week high of the stock was at ₹1,592.55 per share and 52-week low of the stock was at ₹994.35 per share. Eugia Pharma will be manufacturing Dasatinib Tablets of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS). The product is expected to be launched in Q1FY26. The approved product has an estimated market size of $1.8 billion for the twelve months ending February 2025, according to IQVIA MAT. This is the 181st ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products. ALSO READ | Bharti Hexacom hits all time high after 400 MHz deal with with Adani firm About Aurobindo Pharma Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 30+ manufacturing and packaging facilities. Its robust product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic, supported by a strong R&D set-up.
Business Standard
23-04-2025
- Business
- Business Standard
Aurobindo Pharma rallies after arm receives USFDA nod for Dasatinib tablets
Aurobindo Pharma rose 1.81% to Rs 1,209.60 after its wholly owned subsidiary, Eugia Pharma Specialities, received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets. The drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets by Bristol-Myers Squibb Company (BMS). Dasatinib is approved for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults and children, including newly diagnosed cases. It is also indicated for Ph+ CML with resistance or intolerance to prior therapies like imatinib and for Ph+ acute lymphoblastic leukemia (ALL) with treatment resistance or intolerance. The approved product has an estimated market size of US$ 1.8 billion for the twelve months ending February 2025, according to IQVIA MAT. This marks the 181st ANDA approval (including 9 tentative approvals) from Eugia Pharma Specialties Group (EPSG) facilities, which manufacture both oncology oral and sterile specialty products. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries. The companys consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024.
Business Upturn
23-04-2025
- Business
- Business Upturn
Aurobindo Pharma receives USFDA approval for Dasatinib Tablets; Stock jumps
By Aditya Bhagchandani Published on April 23, 2025, 11:26 IST Aurobindo Pharma's wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dasatinib Tablets, available in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg strengths. Dasatinib Tablets are the generic equivalent of Bristol-Myers Squibb's Sprycel Tablets and are indicated for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML) in adults and children, and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) in adults. The company plans to launch the product in the first quarter of FY26. According to IQVIA data, the approved product has an estimated market size of around $1.8 billion (approximately ₹15,000 crore) in the US for the 12-month period ending February 2025. This approval marks the 181st ANDA (Abbreviated New Drug Application), including nine tentative approvals, from Eugia Pharma Specialities Group, which is focused on oncology, critical care, and other specialty therapeutic segments. Meanwhile, Aurobindo Pharma shares rose 1.5% intraday following the announcement. 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. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
