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CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys® (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells.
Aurobindo Pharma's Vice Chairman and Managing Director Mr. Nithyananda Reddy said, 'The CHMP's positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts in building biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies.'
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 company’s 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.
Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of $447 million for the twelve months ending February 2025, according to IQVIA. The company now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA.
The company has also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is $8.5 billion for the twelve months ending February 2025, according to IQVIA.
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.
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 scrip added 2.47% to end at Rs 1,082.55 on Friday, 11 April 2025. The stock market will remain closed today on account of Dr. Babasaheb Ambedkar Jayanti.
The inspection was completed on 10 April 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature.