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  • Aurobindo Pharma Receives USFDA Approval For Memantine Hydrochloride Tablets (Company Update)

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    Shyam Sunder
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    Aurobindo Pharma Limited has received final approval from the USFDA to manufacture and market Memantine Hydrochloride Tablets. The approved product has an estimated market size of US$1. Billion for the twelve months ending August 2015 according to IMS. 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, and ANVISA Brazil.

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    Aurobindo Pharma receives USFDA Approval for Memantine Hydrochloride Tablets [Company Update]

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    Aurobindo Pharma Limited has received final approval from the USFDA to manufacture and market Memantine Hydrochloride Tablets. The approved product has an estimated market size of US$1. Billion for the twelve months ending August 2015 according to IMS. 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, and ANVISA Brazil.

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    Aurobindo Pharma Receives USFDA Approval For Memantine Hydrochloride Tablets (Company Update)

    Diunggah oleh

    Shyam Sunder
    Aurobindo Pharma Limited has received final approval from the USFDA to manufacture and market Memantine Hydrochloride Tablets. The approved product has an estimated market size of US$1. Billion for the twelve months ending August 2015 according to IMS. 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, and ANVISA Brazil.

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    15th October 2015

    Aurobindo Pharma receives USFDA Approval for


    Memantine Hydrochloride Tablets
    Aurobindo Pharma Limited is pleased to announce that the company has received the final
    approval from the US Food & Drug Administration (USFDA) to manufacture and market
    Memantine Hydrochloride Tablets, 5mg and 10mg (ANDA 203175). This approval is an extension
    of tentative approval received on 24 March 2014. The product is ready for launch.
    The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug
    product (RLD) NAMENDA 5mg and 10mg of Forest Laboratories Inc.
    Memantine Hydrochloride Tablets are used for the treatment of moderate to severe dementia of
    the Alzheimer's type. The approved product has an estimated market size of US$1.23 Billion for
    the twelve months ending August 2015 according to IMS.
    Aurobindo now has a total of 215 ANDA approvals (188 Final approvals including 10 from Aurolife
    Pharma LLC and 27 Tentative approvals) from USFDA
    About Aurobindo Pharma Limited:
    Aurobindo Pharma Limited (www.aurobindo.com) (NSE: AUROPHARMA, BSE: 524804, Reuters:
    ARBN.NS, Bloomberg: ARBP:IN), headquartered at Hyderabad, India, manufactures generic
    pharmaceuticals and active pharmaceutical ingredients. The companys manufacturing facilities
    are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA,
    WHO, Health Canada, MCC South Africa, ANVISA Brazil. The companys robust product portfolio
    is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals,
    CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.
    The Company is marketing these products globally, in over 125 countries.

    For further information, please contact:


    Investor Relations
    Aurobindo Pharma Limited
    Corporate Off: WaterMark Building, Level-1
    Plot No.11, Survey No. 9
    Kondapur, Hitech City, Hyderabad
    Reg Off: Plot No. 2, Maitrivihar
    Ameerpet, Hyderabad

    Phone: 040-66725000 / 66725401


    Email:
    ir@aurobindo.com
    Website : www.aurobindo.com

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