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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 1Flagship Biotech International Pvt. Ltd

09 1Fresenius Kabi Austria

10 1Fresenius Kabi USA

11 1Hainan Poly Pharm

12 1Hainan Shuangcheng Pharmaceuticals

13 2Hospira, Inc.

14 1JUNO PHARMACEUTICALS CORP.

15 1Jodas Expoim Pvt. Ltd

16 1Laboratorio Reig Jofre SA

17 1Maia Pharmaceuticals

18 1Meitheal Pharmaceuticals

19 1Pliva Hrvatska

20 2Sandoz B2B

21 1Slate Run Pharmaceuticals

22 1Stanex Drugs and Chemicals

23 1THE MEDICINES COMPANY UK LTD

24 2The Medic Ines Company UK Ltd

25 1The Medicines Company UK Ltd,

26 2Viatris

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PharmaCompass

01

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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

BIVALIRUDIN

Brand Name : BIVALIRUDIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 250MG/VIAL

Packaging :

Approval Date : 2017-05-26

Application Number : 201577

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 250MG/VIAL

Packaging :

Approval Date : 2017-11-22

Application Number : 206551

Regulatory Info : RX

Registration Country : USA

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 250MG/VIAL

Packaging :

Approval Date : 2017-07-06

Application Number : 204876

Regulatory Info : DISCN

Registration Country : USA

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 250MG/VIAL

Packaging :

Approval Date : 2018-07-27

Application Number : 205962

Regulatory Info : RX

Registration Country : USA

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2017-12-21

Application Number : 208374

Regulatory Info : DISCN

Registration Country : USA

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2017-12-21

Application Number : 208374

Regulatory Info : DISCN

Registration Country : USA

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Bivalirudin

Brand Name :

Dosage Form : Injection

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN FOR INJECTION

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 250MG/VIAL

Packaging : 5ML

Approval Date :

Application Number : 2435268

Regulatory Info : Prescription

Registration Country : Canada

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09

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 250MG/VIAL

Packaging :

Approval Date : 2016-10-28

Application Number : 90189

Regulatory Info : RX

Registration Country : USA

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10

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Bivalirudin

Brand Name :

Dosage Form : Injection

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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11

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Bivalirudin

Brand Name :

Dosage Form : Lyo.Inj

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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15

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : ANGIOMAX RTU

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2019-07-25

Application Number : 211215

Regulatory Info : RX

Registration Country : USA

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16

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : ANGIOMAX

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 250MG/VIAL

Packaging : 10X5ML

Approval Date :

Application Number : 2246533

Regulatory Info : Prescription

Registration Country : Canada

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20

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

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

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

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
Antibody Engineering
Not Confirmed
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The Medicines Company UK Ltd,

Country
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Antibody Engineering
Not Confirmed

bivalirudin

Brand Name : Angiox

Dosage Form : POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION

Dosage Strength : 250 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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25

Laboratorio Reig Jofre SA

Country
Antibody Engineering
Not Confirmed
arrow

Laboratorio Reig Jofre SA

Country
arrow
Antibody Engineering
Not Confirmed

bivalirudin

Brand Name : Bivalirudin Reig Jofre

Dosage Form : POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION

Dosage Strength : 250 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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26

THE MEDICINES COMPANY UK LTD

Country
Antibody Engineering
Not Confirmed
arrow

THE MEDICINES COMPANY UK LTD

Country
arrow
Antibody Engineering
Not Confirmed

Bivalirudin

Brand Name : Angiox

Dosage Form : Bivalirudin 250Mg 10 Units Parenteral Use

Dosage Strength : 10 VIALS EV 250 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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27

The Medic Ines Company UK Ltd

Country
Antibody Engineering
Not Confirmed
arrow

The Medic Ines Company UK Ltd

Country
arrow
Antibody Engineering
Not Confirmed

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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28

The Medic Ines Company UK Ltd

Country
Antibody Engineering
Not Confirmed
arrow

The Medic Ines Company UK Ltd

Country
arrow
Antibody Engineering
Not Confirmed

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.

Country
Antibody Engineering
Not Confirmed
arrow

AVIR PHARMA INC.

Country
arrow
Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN INJECTION

Dosage Form : SOLUTION

Dosage Strength : 5MG/ML

Packaging :

Approval Date :

Application Number : 2505517

Regulatory Info : Prescription

Registration Country : Canada

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30

JUNO PHARMACEUTICALS CORP.

Country
Antibody Engineering
Not Confirmed
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JUNO PHARMACEUTICALS CORP.

Country
arrow
Antibody Engineering
Not Confirmed

BIVALIRUDIN

Brand Name : BIVALIRUDIN FOR INJECTION

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 250MG/VIAL

Packaging :

Approval Date :

Application Number : 2511452

Regulatory Info : Prescription

Registration Country : Canada

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