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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

23 1Stanex Drugs and Chemicals

24 1THE MEDICINES COMPANY UK LTD

25 2The Medic Ines Company UK Ltd

26 1The Medicines Company UK Ltd,

27 2Viatris

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PharmaCompass

01

  • 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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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09

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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10

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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11

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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12

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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13

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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14

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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15

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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16

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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17

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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18

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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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19

The Medicines Company UK Ltd,

Country
AMWC Asia-TDAC
Not Confirmed
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The Medicines Company UK Ltd,

Country
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AMWC Asia-TDAC
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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20

Laboratorio Reig Jofre SA

Country
AMWC Asia-TDAC
Not Confirmed
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Laboratorio Reig Jofre SA

Country
arrow
AMWC Asia-TDAC
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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