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    Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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    Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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    Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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    TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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    Fosphenytoin Sodium

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    01 1Dr. Reddy's Laboratories

    02 2American Regent

    03 1Amneal Pharmaceuticals

    04 1Apotex Inc

    05 1Eugia Pharma

    06 4Farbe Firma

    07 1Fresenius Kabi USA

    08 1Frostpharma Ab

    09 1GLAND PHARMA LIMITED

    10 1Hanlim Pharmaceuticals Inc

    11 3Hikma Pharmaceuticals

    12 1Hospira, Inc.

    13 1Igenius Life Sciences

    14 2Lupin Ltd

    15 3ORIFARM GROUP AS

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    01

    Dr. Reddy's Laboratories

    India
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    CPhI WW Frankfurt
    Booth #9.1B48
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Regulatory Info : DISCN

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2007-08-06

    Application Number : 76886

    Regulatory Info : DISCN

    Registration Country : USA

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    02

    American Regent

    U.S.A
    ISPE Annual Meeting
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    American Regent

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2007-08-06

    Application Number : 78277

    Regulatory Info : DISCN

    Registration Country : USA

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    03

    American Regent

    U.S.A
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    American Regent

    U.S.A
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    ISPE Annual Meeting
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    Regulatory Info : DISCN

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2010-05-13

    Application Number : 90099

    Regulatory Info : DISCN

    Registration Country : USA

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    04

    Amneal Pharmaceuticals

    U.S.A
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    Amneal Pharmaceuticals

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2008-03-18

    Application Number : 78476

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Apotex Inc

    Canada
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    Apotex Inc

    Canada
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    ISPE Annual Meeting
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    Regulatory Info : DISCN

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2007-08-06

    Application Number : 78126

    Regulatory Info : DISCN

    Registration Country : USA

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    06

    Fresenius Kabi USA

    U.S.A
    ISPE Annual Meeting
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    Fresenius Kabi USA

    U.S.A
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    ISPE Annual Meeting
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    Regulatory Info : RX

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2007-08-06

    Application Number : 78052

    Regulatory Info : RX

    Registration Country : USA

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    07

    GLAND PHARMA LIMITED

    India
    ISPE Annual Meeting
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    GLAND PHARMA LIMITED

    India
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    ISPE Annual Meeting
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    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2023-10-13

    Application Number : 214926

    Regulatory Info : RX

    Registration Country : USA

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    08

    Hanlim Pharmaceuticals Inc

    South Korea
    ISPE Annual Meeting
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    Hanlim Pharmaceuticals Inc

    South Korea
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    ISPE Annual Meeting
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    Regulatory Info : Generic

    Registration Country : South Korea

    Fosphenytoin

    Brand Name : CELEBYX

    Dosage Form : INJECTION

    Dosage Strength : 75MG

    Packaging : 2mL*10A, 10mL*5A

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    Regulatory Info : Generic

    Registration Country : South Korea

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    09

    Hikma Pharmaceuticals

    United Kingdom
    ISPE Annual Meeting
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    Hikma Pharmaceuticals

    United Kingdom
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    ISPE Annual Meeting
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    Regulatory Info : RX

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    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

    Packaging :

    Approval Date : 2007-08-06

    Application Number : 77481

    Regulatory Info : RX

    Registration Country : USA

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    10

    Hikma Pharmaceuticals

    United Kingdom
    ISPE Annual Meeting
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    Hikma Pharmaceuticals

    United Kingdom
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    ISPE Annual Meeting
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    Regulatory Info : RX

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    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

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    Approval Date : 2007-08-06

    Application Number : 77989

    Regulatory Info : RX

    Registration Country : USA

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    11

    Hikma Pharmaceuticals

    United Kingdom
    ISPE Annual Meeting
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    Hikma Pharmaceuticals

    United Kingdom
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    ISPE Annual Meeting
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    Regulatory Info : RX

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

    Packaging :

    Approval Date : 2009-12-02

    Application Number : 78765

    Regulatory Info : RX

    Registration Country : USA

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    12

    Hospira, Inc.

    U.S.A
    ISPE Annual Meeting
    Not Confirmed
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    Hospira, Inc.

    U.S.A
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    ISPE Annual Meeting
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    Regulatory Info : DISCN

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

    Packaging :

    Approval Date : 2007-08-06

    Application Number : 78158

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Igenius Life Sciences

    India
    ISPE Annual Meeting
    Not Confirmed
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    Igenius Life Sciences

    India
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    ISPE Annual Meeting
    Not Confirmed
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    Registration Country : India

    Fosfenitoina

    Brand Name :

    Dosage Form : Injection

    Dosage Strength : 75mg/2ml

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    Registration Country : India

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    14

    Lupin Ltd

    India
    ISPE Annual Meeting
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    Lupin Ltd

    India
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    ISPE Annual Meeting
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    Regulatory Info : RX

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    FOSPHENYTOIN SODIUM

    Brand Name : SESQUIENT

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)

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    Approval Date : 2020-11-05

    Application Number : 210864

    Regulatory Info : RX

    Registration Country : USA

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    15

    Lupin Ltd

    India
    ISPE Annual Meeting
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    Lupin Ltd

    India
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    ISPE Annual Meeting
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    Regulatory Info : RX

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    FOSPHENYTOIN SODIUM

    Brand Name : SESQUIENT

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)

    Packaging :

    Approval Date : 2020-11-05

    Application Number : 210864

    Regulatory Info : RX

    Registration Country : USA

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    16

    Pfizer Inc

    U.S.A
    ISPE Annual Meeting
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    Pfizer Inc

    U.S.A
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    ISPE Annual Meeting
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    Regulatory Info : RX

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : CEREBYX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

    Packaging :

    Approval Date : 1996-08-05

    Application Number : 20450

    Regulatory Info : RX

    Registration Country : USA

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    17

    Pfizer Inc

    U.S.A
    ISPE Annual Meeting
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    Pfizer Inc

    U.S.A
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    ISPE Annual Meeting
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    Regulatory Info :

    Registration Country : Norway

    Fosphenytoin

    Brand Name : Pro-Epanutin

    Dosage Form : To concentrate the Injection/infusion fluid, resolution

    Dosage Strength : 50 FNE mg/ml

    Packaging : Hood glass

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    18

    Sun Pharmaceutical Industries Limit...

    India
    ISPE Annual Meeting
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    Sun Pharmaceutical Industries Limit...

    India
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

    Packaging :

    Approval Date : 2008-03-18

    Application Number : 78417

    Regulatory Info : RX

    Registration Country : USA

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    19

    Wockhardt

    India
    ISPE Annual Meeting
    Not Confirmed
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    Wockhardt

    India
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    ISPE Annual Meeting
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

    Packaging :

    Approval Date : 2007-08-06

    Application Number : 78137

    Regulatory Info : RX

    Registration Country : USA

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    20

    PHARMOBEDIENT

    Country
    ISPE Annual Meeting
    Not Confirmed
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    PHARMOBEDIENT

    Country
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    ISPE Annual Meeting
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    FOSPHENYTOIN SODIUM

    Brand Name : FOSPHENYTOIN SODIUM

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG PHENYTOIN NA/ML

    Packaging :

    Approval Date : 2010-06-08

    Application Number : 78736

    Regulatory Info : DISCN

    Registration Country : USA

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