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01 5Sanofi

02 2Aspen Pharmacare Holdings

03 1Rusan Pharma

04 2Adcock Ingram

05 1Adelco-Chromatourgia Anthinon E. Colocotronis Bros S.A.

06 3Akrikhin

07 1Bahrain Pharma

08 2Berlin Chemie

09 2Bernofarm Pharmaceutical Company

10 2Boehringer Ingelheim GmbH

11 1DOPHARMA B.V.

12 1Delos Medica

13 1Desma Pharmaceutical Laboratory Sl

14 1Ecosse Limited

15 1Enlie Pharmaceutical Joint Stock Company

16 4Evolan Pharma AB

17 1Faes Farma

18 1Fortune Pharmacal

19 5Grindeks AS

20 1Hi-Tech Pharma

21 3Holden Medical Laboratories Pvt. Ltd

22 3Ipca Laboratories

23 4Johnson & Johnson

24 1Karo Pharma

25 1Labiana Life Sciences S.A

26 1Laboratoria Qualiphar N.V/S.A

27 2Laboratorios Basi

28 1MS Pharma

29 1Mars Therapeutics

30 2Medinfar Consumer Health -Produtos Farmaceuticos, Lda

31 1Medreich

32 1Mint Health Ltd

33 1NM Pharma Limited

34 1NeoFarma Pharmaceuticals Limited

35 2Neopharma

36 3ORIFARM GROUP AS

37 1Omni Protech Drugs

38 2Opel Healthcare Switzerland Ag

39 13Opella Healthcare Group

40 2Opes Health Care

41 1Pharmabart Limited

42 1Qilu Animal Health Products

43 2Reig Jofre

44 1Remedica Limited

45 1SIT LABORATORIO FARMAC. Srl

46 2Scott-Edil Pharmacia

47 4Stallen

48 1Suncare Formulations

49 1Teva Pharmaceutical Industries

50 1Themis Medicare

51 1Unimedic Pharma Ab

52 1United Biomed

53 1Urquima S.A. Grupo Uriach

54 1Varsha Group

55 1Vianex SA Aonyme Commercial-Industrial-, Tourist & Maritime Societe Anonyme Vianex SA

56 2World Medicine

57 1Xepa-Soul Pattinson m SDN BHD

58 2Zenex Animal Health

59 1Zota Healthcare Ltd

60 1iNova Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Bromhexine Hydrochloride

Brand Name : Bisolvon

Dosage Form : Oral Drops

Dosage Strength : 8mg

Packaging :

Approval Date : 17/12/2014

Application Number : 20131228000030

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

02

Bromhexine

Brand Name : Bronkese Compound Linctus

Dosage Form : SYR

Dosage Strength : 4mg/5ml

Packaging : 100X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

03

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info :

Registration Country : India

Bromhexine Hydrochloride

Brand Name : Bromhexine Hydrochloride

Dosage Form : Oral Liquid

Dosage Strength : 0.8mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Rusan Pharma

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Cancelled

Registration Country : Spain

Bromhexine Hydrochloride

Brand Name : Bisolvon Mucolitico

Dosage Form : Soluble Tablet

Dosage Strength : 8MG

Packaging :

Approval Date : 28-09-2011

Application Number : 74772

Regulatory Info : Cancelled

Registration Country : Spain

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Originator

Registration Country : South Africa

Bromhexine Hydrochloride

Brand Name : Bisolvon Linctus DA

Dosage Form : LIQ

Dosage Strength : 4mg/5ml

Packaging : 100X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Originator

Registration Country : South Africa

Bromhexine Hydrochloride

Brand Name : Bisolvon Linctus DA

Dosage Form : LIQ

Dosage Strength : 4mg/5ml

Packaging : 200X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Originator

Registration Country : South Africa

Bromhexine Hydrochloride

Brand Name : Bisolvon 0.2 %

Dosage Form : SLN

Dosage Strength : 10mg/5ml

Packaging : 50X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

08

Bromhexine

Brand Name : Bronkese Compound Linctus

Dosage Form : SYR

Dosage Strength : 4mg/5ml

Packaging : 200X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

09

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name : Hexobim

Dosage Form : SYRUP

Dosage Strength : 4MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Bahrain

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10

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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11

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 8MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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12

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : Tablet

Dosage Strength : 16MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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13

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : ELIXIR

Dosage Strength : 60MG

Packaging : 60ML, 100ML, 120ML

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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14

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : ELIXIR

Dosage Strength : 120MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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15

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : TABLETS

Dosage Strength : 8MG

Packaging : 10x10's

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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16

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : Syrup

Dosage Strength : 0.8MG/1ML

Packaging : 1 Bottle- 125 ML, 200 ML

Approval Date :

Application Number :

Regulatory Info : EU CTD Dossier- Ready

Registration Country : Portugal

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17

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : SYRUP

Dosage Strength : 4MG/5ML

Packaging : Pack Size in UPM - 100 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Jordan

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18

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine; Guaifenesin; Terbutaline

Brand Name :

Dosage Form : SYRUP

Dosage Strength : 8MG; 100MG; 2.5MG

Packaging : 100 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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19

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name : Mucolix

Dosage Form : ELIXER

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Malaysia

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20

PharmaSynergy
Not Confirmed
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PharmaSynergy
Not Confirmed

Bromhexine

Brand Name :

Dosage Form : TABLET

Dosage Strength : 8MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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