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    CPR Salbutamol+Ipratropium Neb (BRODIX PLUS) 35's

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    Racquel Soliven
    This document is a Certificate of Listing of Identical Drug Product from the Philippines Food and Drug Administration certifying the listing of Brodix Plus (Salbutamol (as sulfate) + Ipratropium (as bromide) 2.5 mg/500 mcg per 2.5 mL Solution for Inhalation) manufactured by Ahlcon Parenterals (India) Limited and distributed in the Philippines by Medethix, Inc. The certificate is valid until May 19, 2027 and lists the approved shelf life, storage conditions, packaging, and special conditions for GMP compliance and generic labeling requirements.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    CPR Salbutamol+Ipratropium Neb (BRODIX PLUS) 35's

    Uploaded by

    Racquel Soliven
    69 views2 pages
    This document is a Certificate of Listing of Identical Drug Product from the Philippines Food and Drug Administration certifying the listing of Brodix Plus (Salbutamol (as sulfate) + Ipratropium (as bromide) 2.5 mg/500 mcg per 2.5 mL Solution for Inhalation) manufactured by Ahlcon Parenterals (India) Limited and distributed in the Philippines by Medethix, Inc. The certificate is valid until May 19, 2027 and lists the approved shelf life, storage conditions, packaging, and special conditions for GMP compliance and generic labeling requirements.

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    CPR Salbutamol+Ipratropium neb (BRODIX PLUS) 35's

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    This document is a Certificate of Listing of Identical Drug Product from the Philippines Food and Drug Administration certifying the listing of Brodix Plus (Salbutamol (as sulfate) + Ipratropium (as bromide) 2.5 mg/500 mcg per 2.5 mL Solution for Inhalation) manufactured by Ahlcon Parenterals (India) Limited and distributed in the Philippines by Medethix, Inc. The certificate is valid until May 19, 2027 and lists the approved shelf life, storage conditions, packaging, and special conditions for GMP compliance and generic labeling requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    69 views2 pages

    CPR Salbutamol+Ipratropium Neb (BRODIX PLUS) 35's

    Uploaded by

    Racquel Soliven
    This document is a Certificate of Listing of Identical Drug Product from the Philippines Food and Drug Administration certifying the listing of Brodix Plus (Salbutamol (as sulfate) + Ipratropium (as bromide) 2.5 mg/500 mcg per 2.5 mL Solution for Inhalation) manufactured by Ahlcon Parenterals (India) Limited and distributed in the Philippines by Medethix, Inc. The certificate is valid until May 19, 2027 and lists the approved shelf life, storage conditions, packaging, and special conditions for GMP compliance and generic labeling requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    Republic of the Philippines

    Department of Health
    Food and Drug Administration
    Civic Drive, Filinvest Corporate City
    Alabang, Muntinlupa City

    CERTIFICATE OF LISTING OF IDENTICAL DRUG PRODUCT

    Pursuant to the provisions of Republic Act (R.A.) No. 3720 as amended, known as the Foods, Drugs, Devices and
    Cosmetics Act, and consistent with R.A. No. 6675, known as the Generics Act of 1988 and R.A. No. 9711, otherwise
    known as the Food and Drug Administration Act of 2009, the product described hereunder has been found to conform
    with the requirements and standards for marketing authorization of pharmaceutical products per existing regulations in
    force as of date hereof.

    Registration Number: DRP-1419-04

    Generic Name: Salbutamol (as sulfate) + Ipratropium (as bromide)


    Brand Name: Brodix Plus
    Dosage Strength & Form: 2.5 mg/500 mcg per 2.5 mL Solution for Inhalation
    Pharmacologic Category: Adrenergic in combination with anticholinergic
    Classification: Prescription Drug (Rx)
    Approved Shelf-life: 24 months
    Storage Condition: Store at temperatures not exceeding 30 ºC.
    Packaging: LDPE Nebule x 2.5 mL (Box of 35's)

    Manufacturer: Ahlcon Parenterals (India) Limited


    SP 917-918, Phase III, RIICO Industrial Area, Bhiwadi Dist. Alwar
    (Rajasthan), 301019, India
    Importer: I.E. Medica Inc.
    5F RFM Corporate Center, Pioneer St., Mandaluyong City, Metro
    Manila
    Distributor: Medethix, Inc.
    6/F RFM Corporate Center Pioneer St., Mandaluyong, Metro Manila

    The Certificate of Listing to the above Distributor shall be valid until 19 May 2027, which covers the unexpired term of
    the Principal CPR, subject to the conditions listed on the reverse side. No changes in the ownership, registrant's
    address/location, manufacturer, excipients, formulation, dosage form, strength, therapeutic indication, manufacturing
    process, labelling and commercial presentation, and packaging of the Principal product covered by the Principal CPR
    without prior approval of this Office.

    This Certificate of Listing is subject to suspension, cancellation or recall should any violation of R.A. No. 3720, R.A.
    No. 6675 and R.A. No. 9711 and/or regulations issued thereunder involving the product be committed.

    Witness My Hand and Seal of this Office, this 25 February 2022

    By the Authority of the Director-General Per FDA Order No. 2016-005:

    Jesusa Joyce N. Cirunay, RPh

    Director IV, Center for Drug Regulation and Research


    This electronic-CLIDP (eCLIDP) is computer generated and does not require signature

    Registration Number: DRP-1419-04

    SPECIAL CONDITION:

    Provided that nothing in the registration of the product herein granted shall be interpreted or construed as an
    endorsement or representation by FDA, that registrant has the right or privilege to the use of the name or brand so
    registered, Registrant hereby agrees and affirms to indemnify and/or hold FDA free and harmless against any and all
    third-party claims on infringement of patent, trademark or intellectual property right arising from the registration of the
    product.

    Subject to post-marketing surveillance of the marketing authorization holder’s strict compliance to the Generic
    Labeling Requirements following the applicable provisions of A.O No. 2016-0008 for drug products for human use and
    A.O. No. 105 s. 1991 for veterinary drug products.

    Submit a Certificate of Good Manufacturing Practice (GMP) Compliance of Foreign Drug Manufacturer(s) within the
    validity of this CPR in accordance with A. O. No. 2013-0022 and FDA Circular 2014-016.

    REMARKS:

    This Certificate of Listing of Identical Drug Product (CLIDP) is revalidated to reflect the full validity until 19 May
    2027.

    20220121140725

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