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    01 1Dr. Reddy's Laboratories

    02 1AVIR PHARMA INC.

    03 1Accord healthcare

    04 2Apotex Inc

    05 1Arrotex Pharmaceuticals

    06 1Aurobindo Pharma Limited

    07 2Baxter Healthcare Corporation

    08 1FORMATIVE PHARMA INC.

    09 1Flagship Biotech International Pvt. Ltd

    10 1Fresenius Kabi Austria

    11 1Fresenius Kabi USA

    12 1Hainan Poly Pharm

    13 1Hainan Shuangcheng Pharmaceuticals

    14 2Hospira, Inc.

    15 1JUNO PHARMACEUTICALS CORP.

    16 1Jodas Expoim Pvt. Ltd

    17 1Laboratorio Reig Jofre SA

    18 1Maia Pharmaceuticals

    19 1Meitheal Pharmaceuticals

    20 1Pliva Hrvatska

    21 2Sandoz B2B

    22 1Slate Run Pharmaceuticals

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    01

    Dr. Reddy's Laboratories

    India
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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

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    Approval Date : 2017-05-26

    Application Number : 201577

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    02

    Accord healthcare

    United Kingdom
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    Accord healthcare

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    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

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    Approval Date : 2017-11-22

    Application Number : 206551

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    Registration Country : USA

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    03

    Apotex Inc

    Canada
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    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

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    Approval Date : 2017-07-06

    Application Number : 204876

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    Registration Country : USA

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    Aurobindo Pharma Limited

    India
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    Aurobindo Pharma Limited

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    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

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    Approval Date : 2018-07-27

    Application Number : 205962

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    Baxter Healthcare Corporation

    U.S.A
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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 250MG/50ML (5MG/ML)

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    Approval Date : 2017-12-21

    Application Number : 208374

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    Baxter Healthcare Corporation

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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 500MG/100ML (5MG/ML)

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    Approval Date : 2017-12-21

    Application Number : 208374

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    07

    Flagship Biotech International Pvt....

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    Flagship Biotech International Pvt....

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    Fresenius Kabi Austria

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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN FOR INJECTION

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 250MG/VIAL

    Packaging : 5ML

    Approval Date :

    Application Number : 2435268

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    Registration Country : Canada

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    09

    Fresenius Kabi USA

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    Fresenius Kabi USA

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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

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    Approval Date : 2016-10-28

    Application Number : 90189

    Regulatory Info : RX

    Registration Country : USA

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    10

    Hainan Poly Pharm

    China
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    Hainan Poly Pharm

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    Bivalirudin

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    Dosage Form : Injection

    Dosage Strength : 250MG

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    11

    Hainan Shuangcheng Pharmaceuticals

    China
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    Hainan Shuangcheng Pharmaceuticals

    China
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    Regulatory Info : RX

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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date : 2019-10-23

    Application Number : 210031

    Regulatory Info : RX

    Registration Country : USA

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    12

    Hospira, Inc.

    U.S.A
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    Hospira, Inc.

    U.S.A
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    Regulatory Info : DISCN

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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date : 2015-07-14

    Application Number : 90811

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Hospira, Inc.

    U.S.A
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    Hospira, Inc.

    U.S.A
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    PharmaVenue
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    Regulatory Info : DISCN

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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date : 2015-07-14

    Application Number : 90816

    Regulatory Info : DISCN

    Registration Country : USA

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    14

    Jodas Expoim Pvt. Ltd

    India
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    Jodas Expoim Pvt. Ltd

    India
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    Regulatory Info : Generic

    Registration Country : India

    Bivalirudin

    Brand Name :

    Dosage Form : Lyo.Inj

    Dosage Strength : 250MG

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    Regulatory Info : Generic

    Registration Country : India

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    15

    Maia Pharmaceuticals

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    Maia Pharmaceuticals

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    BIVALIRUDIN

    Brand Name : ANGIOMAX RTU

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : 250MG/50ML (5MG/ML)

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    Approval Date : 2019-07-25

    Application Number : 211215

    Regulatory Info : RX

    Registration Country : USA

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    16

    Meitheal Pharmaceuticals

    U.S.A
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    Meitheal Pharmaceuticals

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    PharmaVenue
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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date : 2018-07-16

    Application Number : 91602

    Regulatory Info : RX

    Registration Country : USA

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    17

    Pliva Hrvatska

    Croatia
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    Pliva Hrvatska

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    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 91206

    Regulatory Info :

    Registration Country : USA

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    18

    Sandoz B2B

    Switzerland
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    Sandoz B2B

    Switzerland
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    BIVALIRUDIN

    Brand Name : ANGIOMAX

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date : 2000-12-15

    Application Number : 20873

    Regulatory Info : RX

    Registration Country : USA

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    19

    Sandoz B2B

    Switzerland
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    Sandoz B2B

    Switzerland
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    PharmaVenue
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    Registration Country : Canada

    BIVALIRUDIN

    Brand Name : ANGIOMAX

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 250MG/VIAL

    Packaging : 10X5ML

    Approval Date :

    Application Number : 2246533

    Regulatory Info :

    Registration Country : Canada

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    20

    Slate Run Pharmaceuticals

    U.S.A
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    Slate Run Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date : 2021-05-28

    Application Number : 213078

    Regulatory Info : RX

    Registration Country : USA

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    21

    Stanex Drugs and Chemicals

    India
    PharmaVenue
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    Stanex Drugs and Chemicals

    India
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    Regulatory Info :

    Registration Country : India

    Bivalirudin

    Brand Name :

    Dosage Form : Injection

    Dosage Strength : 250MG/ML

    Packaging : 10 ml

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    22

    Viatris

    U.S.A
    PharmaVenue
    Not Confirmed
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    Viatris

    U.S.A
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    Registration Country : USA

    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 91468

    Regulatory Info :

    Registration Country : USA

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    23

    Viatris

    U.S.A
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    Viatris

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    Regulatory Info : RX

    Registration Country : USA

    BIVALIRUDIN

    Brand Name : BIVALIRUDIN

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date : 2018-06-01

    Application Number : 202471

    Regulatory Info : RX

    Registration Country : USA

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    24

    The Medicines Company UK Ltd,

    Country
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    The Medicines Company UK Ltd,

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    Regulatory Info :

    Registration Country : Sweden

    bivalirudin

    Brand Name : Angiox

    Dosage Form : POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION

    Dosage Strength : 250 MG

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    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Laboratorio Reig Jofre SA

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    Regulatory Info :

    Registration Country : Sweden

    bivalirudin

    Brand Name : Bivalirudin Reig Jofre

    Dosage Form : POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION

    Dosage Strength : 250 MG

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    Approval Date :

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    Regulatory Info :

    Registration Country : Sweden

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    THE MEDICINES COMPANY UK LTD

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    Regulatory Info :

    Registration Country : Italy

    Bivalirudin

    Brand Name : Angiox

    Dosage Form : Bivalirudin 250Mg 10 Units Parenteral Use

    Dosage Strength : 10 VIALS EV 250 mg

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    Regulatory Info :

    Registration Country : Italy

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    The Medic Ines Company UK Ltd

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    Regulatory Info :

    Registration Country : Norway

    Bivalirudin

    Brand Name : Angiox

    Dosage Form : Powder to concentrate to the Injection/infusion fluid, resolution

    Dosage Strength : 250 mg

    Packaging : Hood glass

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    Regulatory Info :

    Registration Country : Norway

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    The Medic Ines Company UK Ltd

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    Regulatory Info :

    Registration Country : Norway

    Bivalirudin

    Brand Name : Angiox

    Dosage Form : Powder to concentrate to the Injection/infusion fluid, resolution

    Dosage Strength : 250 mg

    Packaging : Hood glass

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    29

    AVIR PHARMA INC.

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    Regulatory Info :

    Registration Country : Canada

    BIVALIRUDIN

    Brand Name : BIVALIRUDIN INJECTION

    Dosage Form : SOLUTION

    Dosage Strength : 5MG/ML

    Packaging :

    Approval Date :

    Application Number : 2505517

    Regulatory Info :

    Registration Country : Canada

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    FORMATIVE PHARMA INC.

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    Regulatory Info :

    Registration Country : Canada

    BIVALIRUDIN

    Brand Name : BIVALIRUDIN FOR INJECTION

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 250MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 2539586

    Regulatory Info :

    Registration Country : Canada

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