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    Approved Drug Products of Granules India Limited listed in the FDA Orange Book. Original Data : FDA Website

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    GRANULES INDIA LIMITED

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    DEVELOPMENTS

    DOSSIERs // Finished Dosage Formulations

    Key Products KEY PRODUCTS

    • Avatrombopag Maleate

    • Bupropion Hydrobromide

    • Bupropion Hydrochloride

    • Cabozantinib

    • Elacestrant

    • Eltrombopag

    • Esomeprazole Magnesium

    • Esomeprazole Sodium

    • Gabapentin

    • Gabapentin Enacarbil

    • Guaifenesin

    • Metformin

    • Methocarbamol

    • Metoprolol Fumarate

    • Metoprolol Succinate

    • Metoprolol Tartrate

    • Paracetamol

    • Ruxolitinib Phosphate

    • Sitagliptin Hydrochloride

    • Sitagliptin Malate

    • Sitagliptin Phosphate

    • Trazodone Hydrochloride

    INSPECTIONS & REGISTRATIONS

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    Granules India
    Granules India Limited
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    Country
    Country
    India
    Address
    Address
    2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500 081 (TG)
    Telephone
    Telephone
    +91 4069043500
    Client Email
    Email
    mail@granulesindia.com
    Client Website
    Website
    https://granulesindia.com/
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    https://www.linkedin.com/company/granules-india-limited/
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    https://twitter.com/GranulesIndia
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    • FDA
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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    ACETAMINOPHEN

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    TABLET, EXTENDED R...
    650MG
    2019-04-16
    211544
    ACETAMINOPHEN
    OTC
    No
    Granules India

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    ACETAMINOPHEN; ASPIRIN; CAFFEINE

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    TABLET; ORAL
    250MG;250MG;65MG
    2021-02-23
    214039
    ACETAMINOPHEN, ASP...
    OTC
    No
    Granules India

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    ACETAMINOPHEN; BUTALBITAL

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    CAPSULE; ORAL
    300MG;50MG
    2019-11-22
    213115
    BUTALBITAL AND ACE...
    RX
    No
    AA
    Granules India

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    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

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    TABLET; ORAL
    325MG;50MG;40MG
    2008-12-01
    40864
    BUTALBITAL, ACETAM...
    RX
    No
    AA
    Granules India

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    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

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    CAPSULE; ORAL
    300MG;50MG;40MG
    2020-04-08
    213321
    BUTALBITAL, ACETAM...
    RX
    No
    AA
    Granules India

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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;5MG
    2020-01-03
    211729
    HYDROCODONE BITART...
    DISCN
    No
    Granules India

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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;7.5MG
    2020-01-03
    211729
    HYDROCODONE BITART...
    DISCN
    No
    Granules India

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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;10MG
    2020-01-03
    211729
    HYDROCODONE BITART...
    DISCN
    No
    Granules India

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    ACETAMINOPHEN; IBUPROFEN

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    TABLET; ORAL
    250MG;125MG
    2023-07-13
    216592
    ACETAMINOPHEN AND ...
    OTC
    No
    Granules India

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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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    TABLET; ORAL
    325MG;2.5MG
    2019-10-31
    211708
    OXYCODONE AND ACET...
    DISCN
    No
    Granules India

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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    325MG;5MG
    2019-10-31
    211708
    OXYCODONE AND ACET...
    DISCN
    No
    Granules India

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    Booth #22A34

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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    325MG;7.5MG
    2019-10-31
    211708
    OXYCODONE AND ACET...
    DISCN
    No
    Granules India

    CPhI Worldwide, Milan

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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    325MG;10MG
    2019-10-31
    211708
    OXYCODONE AND ACET...
    DISCN
    No
    Granules India

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    1.25MG;1.25MG;1.25...
    2021-12-28
    215771
    DEXTROAMP SACCHARA...
    RX
    No
    AB
    Granules India

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    1.875MG;1.875MG;1....
    2021-12-28
    215771
    DEXTROAMP SACCHARA...
    RX
    No
    AB
    Granules India

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    2.5MG;2.5MG;2.5MG;...
    2021-12-28
    215771
    DEXTROAMP SACCHARA...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    3.125MG;3.125MG;3....
    2021-12-28
    215771
    DEXTROAMP SACCHARA...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    3.75MG;3.75MG;3.75...
    2021-12-28
    215771
    DEXTROAMP SACCHARA...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    5MG;5MG;5MG;5MG
    2021-12-28
    215771
    DEXTROAMP SACCHARA...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    7.5MG;7.5MG;7.5MG;...
    2021-12-28
    215771
    DEXTROAMP SACCHARA...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    1.25MG;1.25MG;1.25...
    2023-01-23
    217027
    DEXTROAMP SACCHARA...
    RX
    No
    AB1
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    2.5MG;2.5MG;2.5MG;...
    2023-01-23
    217027
    DEXTROAMP SACCHARA...
    RX
    No
    AB1
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    3.75MG;3.75MG;3.75...
    2023-01-23
    217027
    DEXTROAMP SACCHARA...
    RX
    No
    AB1
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    5MG;5MG;5MG;5MG
    2023-01-23
    217027
    DEXTROAMP SACCHARA...
    RX
    No
    AB1
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    6.25MG;6.25MG;6.25...
    2023-01-23
    217027
    DEXTROAMP SACCHARA...
    RX
    No
    AB1
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    7.5MG;7.5MG;7.5MG;...
    2023-01-23
    217027
    DEXTROAMP SACCHARA...
    RX
    No
    AB1
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    AMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    5MG
    2019-08-05
    212619
    AMPHETAMINE SULFAT...
    RX
    No
    AA
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    AMPHETAMINE SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    10MG
    2019-08-05
    212619
    AMPHETAMINE SULFAT...
    RX
    No
    AA
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    BUPROPION HYDROCHLORIDE

    PDF Supplier PDF
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    TABLET, EXTENDED R...
    150MG
    2022-02-02
    215568
    BUPROPION HYDROCHL...
    RX
    No
    AB3
    Granules India

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    BUPROPION HYDROCHLORIDE

    PDF Supplier PDF
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    TABLET, EXTENDED R...
    300MG
    2022-02-02
    215568
    BUPROPION HYDROCHL...
    RX
    No
    AB3
    Granules India

    CPhI Worldwide, Milan

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    CETIRIZINE HYDROCHLORIDE

    PDF Supplier PDF
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    TABLET; ORAL
    10MG
    2017-12-22
    209274
    CETIRIZINE HYDROCH...
    OTC
    No
    Granules India

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    COLCHICINE

    PDF Supplier PDF
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    TABLET; ORAL
    0.6MG
    2020-02-05
    210425
    COLCHICINE
    RX
    No
    AB
    Granules India

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    COLCHICINE

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    CAPSULE; ORAL
    0.6MG
    2024-04-29
    210757
    COLCHICINE
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    DEXMETHYLPHENIDATE HYDROCHLORIDE

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    CAPSULE, EXTENDED ...
    5MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    10MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    DEXMETHYLPHENIDATE HYDROCHLORIDE

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    CAPSULE, EXTENDED ...
    15MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    20MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    25MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    30MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    35MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    CAPSULE, EXTENDED ...
    40MG
    2020-09-09
    213813
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

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    TABLET; ORAL
    25MG;220MG
    2020-09-24
    213663
    NAPROXEN SODIUM AN...
    OTC
    No
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

    envelop Contact Supplier

    Contact Supplier
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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    DOFETILIDE

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    CAPSULE; ORAL
    0.125MG
    2021-10-14
    212750
    DOFETILIDE
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    DOFETILIDE

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    URL Supplier Web Content
    CAPSULE; ORAL
    0.25MG
    2021-10-14
    212750
    DOFETILIDE
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    DOFETILIDE

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    URL Supplier Web Content
    CAPSULE; ORAL
    0.5MG
    2021-10-14
    212750
    DOFETILIDE
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

    envelop Contact Supplier

    Contact Supplier
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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    ESOMEPRAZOLE MAGNESIUM

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    CAPSULE, DELAYED R...
    EQ 20MG BASE
    2023-10-18
    217427
    ESOMEPRAZOLE MAGNE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

    envelop Contact Supplier

    Contact Supplier
    • FDA
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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    ESOMEPRAZOLE MAGNESIUM

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    URL Supplier Web Content
    CAPSULE, DELAYED R...
    EQ 40MG BASE
    2023-10-18
    217427
    ESOMEPRAZOLE MAGNE...
    RX
    No
    AB
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Contact Supplier
    • FDA
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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    FEXOFENADINE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    60MG
    2019-10-18
    211075
    FEXOFENADINE HYDRO...
    OTC
    No
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    FEXOFENADINE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    180MG
    2019-10-18
    211075
    FEXOFENADINE HYDRO...
    OTC
    No
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

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    Contact Supplier
    • FDA
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    Virtual BoothGranules India Limited has world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    FLUOXETINE HYDROCHLORIDE

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    URL Supplier Web Content
    CAPSULE; ORAL
    EQ 10MG BASE
    2008-01-16
    78143
    FLUOXETINE HYDROCH...
    DISCN
    No
    Granules India

    CPhI Worldwide, Milan

    Booth #22A34

    envelop Contact Supplier

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