Aurobindo Pharma arm bags USFDA nod for cancer drug Pazopanib
Hyderabad: Aurobindo Pharma Limited has announced that its wholly owned subsidiary company, EugiaPharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Votrient Tablets, 200 mg, of Novartis Pharmaceuticals Corporation.
The product is expected to be launched in Q4FY25.
The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA.
This is the 179 th ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Medical Dialogues team had earlier reported that Aurobindo Pharma, Dr Reddy's Laboratories, and Hetero Labs and 3 other pharmaceutical companies had signed memorandums of understanding (MoUs) with the Telangana government for setting up facilities in the Pharma City with an investment of over Rs 5,260 crore.
Aurobindo Pharma Limited 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 has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
