Aurobindo Pharma announced Thursday the company has received final approval 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.

Shares of the company declined Rs 12.3, or 1.5%, to trade at Rs 805.00. The total volume of shares traded was 196,804 at the BSE (2.11 p.m., Thursday).