aurobindo pharma receives usfda approval for ibandronate sodium injection [company update]

Upload: shyam-sunder

Post on 07-Aug-2018

212 views

Category:

Documents


0 download

TRANSCRIPT

  • 8/20/2019 Aurobindo Pharma receives USFDA Approval for Ibandronate Sodium Injection [Company Update]

    1/1

     

    20th August 2015

    Aurobindo Pharma receives USFDA Approval for Ibandronate Sodium Injection

    Aurobindo Pharma Limited is pleased to announce that the company has received final approvalsfrom the US Food & Drug Administration (USFDA) to manufacture and market Ibandronate SodiumInjection, 3mg/3mL (1mg/mL), (ANDA 205332).

    Ibandronate Sodium Injection, 3mg/3mL (1mg/mL) is bioequivalent and therapeutically equivalentto the reference listed drug product (RLD) Boniva® Injection, 3mg/3mL (1mg/mL) of Hoffmann-LaRoche, Inc. Ibandronate Sodium Injection is indicated for the treatment of osteoporosis inpostmenopausal 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 bemarketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC

    About Aurobindo Pharma Limited:Aurobindo Pharma Limited (www.aurobindo.com), headquartered at Hyderabad, India, manufactures genericpharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved byseveral leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa,ANVISA Brazil. The company’s robust product portfolio is spread over 6 major therapeutic/product areasencompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by anoutstanding R&D set-up. The Company is marketing these products globally, in over 125 countries.

    For further information, please contact:

    Investor RelationsAurobindo Pharma Limited

    Corporate Off: WaterMark Building, Level-1Plot No.11, Survey No. 9Kondapur, Hitech City, Hyderabad

    Reg Off: Plot No. 2, MaitriviharAmeerpet, Hyderabad

    Phone: 040-66725000 / 66725401Email: [email protected] : www.aurobindo,.com