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01 5Sanofi

02 2Aspen Pharmacare Holdings

03 1Rusan Pharma

04 2Adcock Ingram

05 3Akrikhin

06 1Bahrain Pharma

07 2Bernofarm Pharmaceutical Company

08 2Boehringer Ingelheim GmbH

09 1Desma Pharmaceutical Laboratory Sl

10 1Enlie Pharmaceutical Joint Stock Company

11 4Evolan Pharma AB

12 1Faes Farma

13 1Fortune Pharmacal

14 1Hi-Tech Pharma

15 3Holden Medical Laboratories Pvt. Ltd

16 3Ipca Laboratories

17 4Johnson & Johnson

18 1Karo Pharma

19 1Labiana Life Sciences S.A

20 2Laboratorios Basi

21 1MS Pharma

22 1Mars Therapeutics

23 1Medreich

24 2Neopharma

25 1ORIFARM GROUP AS

26 1Omni Protech Drugs

27 2Opel Healthcare Switzerland Ag

28 9Opella Healthcare Group

29 2Opes Health Care

30 1Qilu Animal Health Products

31 2Reig Jofre

32 1SIT LABORATORIO FARMAC. Srl

33 2Scott-Edil Pharmacia

34 4Stallen

35 1Suncare Formulations

36 1Teva Pharmaceutical Industries

37 1Themis Medicare

38 1Unimedic Pharma Ab

39 1United Biomed

40 1Urquima S.A. Grupo Uriach

41 1Varsha Group

42 2World Medicine

43 1Xepa-Soul Pattinson m SDN BHD

44 2Zenex Animal Health

45 1Zota Healthcare Ltd

46 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 :

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 : 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

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 : 200X1mg/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 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

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 : Cancelled

Registration Country : Spain

Bromhexine Hydrochloride

Brand Name : Bisolvon Mucolitico

Dosage Form : Soluble Tablet

Dosage Strength : 8MG

Packaging :

Approval Date : 2011-09-28

Application Number : 74772

Regulatory Info : Cancelled

Registration Country : Spain

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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
arrow
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
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

ISPE Annual Meeting
Not Confirmed
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arrow
ISPE Annual Meeting
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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