Aurobindo Pharma arm bags USFDA nod for cancer drug Bortezomib
Hyderabad: Drugmaker, Aurobindo Pharma Limited, has recently announced that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bortezomib for injection, 3.5 mg.
Bortezomib for Injection, 3.5 mg/vial (Single-Dose Vial) to be bioequivalent and therapeutically equivalent to the Velcade for Injection 3.5 mg/vial, of Takeda Pharmaceuticals U.S.A. Inc.
The product is being launched immediately. The approved product has a market size of US$ 1172 million for the twelve months ending March 2022, according to IQVIA.
This is the 136th ANDA (including 7 tentative approvals) to be out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Read also: Aurobindo Pharma acquires domestic formulation business of Veritaz for Rs 171 crore
Bortezomib for injection is indicated for the treatment of
• Adult patients with multiple myeloma (cancer of plasma cells)
• Also used to treat adult patients with mantle cell lymphoma (cancer of lymph nodes)
Eugia Pharma Specialities Ltd. had earlier received a 505(b)(2) NDA approval from the U.S.Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials.
Read also: Aurobindo Pharma Arm Gets USFDA Okay For Cyclophosphamide Injection
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 155 countries.
The Company has 26 manufacturing and packaging facilities that are approved by leading 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, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
