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01 1Aspen Pharmacare Holdings

02 10Orion Corporation

03 2Ethypharm

04 3Ever Pharma

05 5Accord healthcare

06 1Actavis Inc

07 4Altan Pharma

08 1American Regent

09 4Amneal Pharmaceuticals

10 1Auro Pharma Inc

11 3Aurobindo Pharma Limited

12 6B. Braun Melsungen AG

13 3Baxter Healthcare Corporation

14 3Bayer AG

15 2BioXcel Therapeutics

16 2Cuckos

17 2DECHRA VETERINARY PRODUCTS INC.

18 1Darou Darman Arang

19 1Dong Bang Co., Ltd

20 1EQL Pharma

21 1EUGIA PHARMA INC.

22 1Eurofarma Laboratorios S.A

23 2Fresenius Kabi AB Brunna

24 3Fresenius Kabi AG

25 5Fresenius Kabi USA

26 3GLAND PHARMA LIMITED

27 1Grey Wolf Animal Health

28 1Grindeks AS

29 4HQ SPCLT PHARMA

30 8Hikma Pharmaceuticals

31 5Hospira, Inc.

32 3JUNO PHARMACEUTICALS CORP.

33 6Jiangsu Hengrui Medicine

34 1Juno Pharma SA (Pty) Ltd

35 2Kalcex

36 1LABORATORIOS NORMON SA

37 3Labatec Pharm

38 1Lamar International (Pty) Ltd

39 1Lorien Laboratories Sl

40 2MODERN VETERINARY THERAPEUTICS LLC

41 1Meitheal Pharmaceuticals

42 2Milla Pharmaceuticals

43 1Montage Laboratories

44 3Orion Pharma

45 3PH HEALTH

46 3Pfizer Inc

47 1Pharmacorp (Pty) Ltd

48 1Piramal Enterprises Limited

49 1Polifarma

50 2Recipharm AB

51 1Rising Pharmaceuticals Inc

52 1Sandoz B2B

53 2Somerset Pharmaceuticals Inc

54 1Sun Pharmaceutical Industries Limited

55 3Tagi Pharma

56 3Teva Pharmaceutical Industries

57 3Themis Medicare

58 4Viatris

59 1Viatris South Africa (Pty) Ltd

60 3WILSHIRE PHARMS INC

61 1Yichang Humanwell Pharmaceutical

62 1Zydus Pharmaceuticals

63 1Blank

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PharmaCompass

01

Dexmedetomidine

Brand Name : Eccladex

Dosage Form : INF

Dosage Strength : 100mcg/ml

Packaging : 2X5mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

02

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Dexmedetomidine Hydrochloride

Brand Name :

Dosage Form : Solution for Infusion

Dosage Strength : 4MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Regulatory Info :

Registration Country : Austria

Dexmedetomidine

Brand Name :

Dosage Form : Concentrate for Solution for Infusion

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Austria

Ever Pharma CB

05

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

06

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

07

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate to the infusion fluid, resolution

Dosage Strength : 100 mcg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

08

Dexmedetomidinhydroklorid

Brand Name : Dexdor

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mcg/ml

Packaging :

Approval Date : 16/09/2011

Application Number : 20101005000010

Regulatory Info : Approved

Registration Country : Sweden

Fermion Orion Company Banner

09

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : DEXDOMITOR

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging : 10ML

Approval Date :

Application Number : 2333929

Regulatory Info : Prescription

Registration Country : Canada

Fermion Orion Company Banner

10

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : SILEO

Dosage Form : GEL

Dosage Strength : 0.1MG/ML

Packaging :

Approval Date :

Application Number : 2530392

Regulatory Info : Prescription

Registration Country : Canada

Fermion Orion Company Banner

11

Dexmedetomidine Hydrochloride

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 2018-09-17

Application Number : 111718004

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

12

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 2011-11-10

Application Number : 11718006

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

13

Dexmedetomidine

Brand Name : Dexdor

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 2011-11-10

Application Number : 11718002

Regulatory Info : Authorized

Registration Country : Spain

Fermion Orion Company Banner

14

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Regulatory Info :

Registration Country : France

Dexmedetomidine Hydrochloride

Brand Name :

Dosage Form : Vial

Dosage Strength : 100MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

15

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Regulatory Info : Approved

Registration Country : Sweden

Dexmedetomidinhydroklorid

Brand Name : Dexmedetomidine Ever Pharma

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mcg/ml

Packaging :

Approval Date : 08/02/2018

Application Number : 20160402000092

Regulatory Info : Approved

Registration Country : Sweden

Ever Pharma CB

16

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Regulatory Info : Authorized

Registration Country : Spain

Dexmedetomidine Hydrochloride

Brand Name : Dexmedetomidina Ever Pharma

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 100MCG

Packaging :

Approval Date : 2018-03-22

Application Number : 82586

Regulatory Info : Authorized

Registration Country : Spain

Ever Pharma CB

17

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : PRECEDEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Packaging :

Approval Date : 1999-12-17

Application Number : 21038

Regulatory Info : RX

Registration Country : USA

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18

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : PRECEDEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Packaging :

Approval Date : 2013-03-13

Application Number : 21038

Regulatory Info : RX

Registration Country : USA

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19

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : PRECEDEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Packaging :

Approval Date : 2013-03-13

Application Number : 21038

Regulatory Info : RX

Registration Country : USA

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20

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

DEXMEDETOMIDINE HYDROCHLORIDE

Brand Name : PRECEDEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

Packaging :

Approval Date : 2014-11-14

Application Number : 21038

Regulatory Info : RX

Registration Country : USA

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