Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Injection, 3mg/3mL (1mg/mL), (ANDA 205332). Ibandronate Sodium Injection, 3mg/3mL (1mg/mL) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Boniva Injection, 3mg/3mL (1mg/mL) of Hoffmann-La Roche, Inc. Ibandronate Sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women.
Aurobindo now has 14 ANDAs (represented by 11 product classes) approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC.
Aurobindo Pharma, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
