Ipratropium Bromide, (exo,syn)-Isomer | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Ipratropium Bromide, (exo,syn)-Isomer
South Africa

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Ipratropium Bromide, (exo,syn)-Isomer

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 10 USDMF, 9 CEP/COS, 1 JDMF, 5 EU WC, 9 KDMF, 14 NDC API, 20 Listed Suppliers, $ API Reference Price

36 API Suppliers
10 USDMF
9 CEP/COS
1 JDMF
5 EU WC
9 KDMF
14 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

192 FDF Dossiers, 45 FDA Orange Book, 81 Europe, 18 Canada, 5 Australia, 23 South Africa, 20 Listed Dossiers

192 FDF Dossiers
45 FDA Orange Book
81 Europe
18 Canada
5 Australia
23 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SPRAY, METERED;NASAL - 0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

5 Actylis, 1 Finar

5 Actylis
1 Finar

EXCIPIENTS BY APPLICATIONS

4 Parenteral, 2 Solubilizers

4 Parenteral
2 Solubilizers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 15 News #PharmaBuzz

1 Data Compilation #PharmaFlow
15 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 56 Regulatory FDF Prices

1 US Medicaid Prescriptions
56 Regulatory FDF Prices

MARKET PLACE

11 APIs, 6 FDF Dossiers, 1 EXCIPIENTS

11 APIs
6 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

5 US Patents, 1 Health Canada Patents

5 US Patents
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 9 Others

4 EDQM
9 Others

$ API Ref.Price (USD/KG) : 4,461 Xls

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23 All

01 1Pharmacare Limited, Woodmead

02 4Adcock Ingram Critical Care (Pty) Ltd

03 1Arrow Pharma South Africa (Pty) Ltd

04 5Cipla Medpro (Pty) Ltd

05 9Ingelheim Pharmaceuticals (Pty) Ltd

06 2Medivision (Pty) Ltd

07 1Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

23 All

01 13Ipratropium Bromide

02 1Ipratropium Bromide Monohydrate

03 8Ipratropium bromide

04 1Ipratropium bromide anhydrous

filter Dosage Form Reset all filters

23 All

01 1CAP

02 6INH

03 8NEB

04 4SOL

05 4UDV

filter Brand Name Reset all filters

23 All

01 1ADCO Combineb

02 1Atrovent 0.025 %

03 1Atrovent 0.25 UDV

04 1Atrovent 0.5 UDV

05 1Atrovent 20 HFA

06 1Atrovent Beta U.D.V

07 1Co-Iprasal Solution

08 1Combivent

09 1Combivent U.D.V.

10 1Duolin HFA Inhaler

11 1Duolin Respules

12 1Duovent HFA

13 1Gericomplex

14 1Iprabut

15 1Ipvent 40 Hfa

16 1Ipvent Respules

17 1Ipvent-40

18 1Sabax Ipratropium Br 0,25Mg/2Ml

19 1Sabax Ipratropium Br 0,5Mg/2Ml

20 1Sabax Nebrafen

21 2Salipra

22 1Tropivent

Vamsi labs Ipratropium Bromide

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Specialty & Agro Chemical

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Iprabut

Dosage Form : NEB

Dosage Strength : 0.5mg/2.5ml

Packaging : 60X1mg/2.5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Sabax Nebrafen

Dosage Form : SOL

Dosage Strength : 2g

Packaging : 60X1mg/4ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : ADCO Combineb

Dosage Form : SOL

Dosage Strength : 0.52 mg/2.5ml

Packaging : 2.5X60mg/2.5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Sabax Ipratropium Br 0,25Mg/2Ml

Dosage Form : SOL

Dosage Strength : 1g/2 ml

Packaging : 2X60mg/2ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Sabax Ipratropium Br 0,5Mg/2Ml

Dosage Form : SOL

Dosage Strength : 1g/2 ml

Packaging : 2X60mg/2ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Arrow Pharma South Africa (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Arrow Pharma South Africa (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Tropivent

Dosage Form : NEB

Dosage Strength : 250mcg/ml

Packaging : 2.5X60mcg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Duolin Respules

Dosage Form : NEB

Dosage Strength : 0.5mg/2.5ml

Packaging : 60X1mg/2.5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Ipvent-40

Dosage Form : INH

Dosage Strength : 40mcg

Packaging : 1X1mcg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Ipvent Respules

Dosage Form : NEB

Dosage Strength : 0.5mg/2ml

Packaging : 60X1mg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Cipla Medpro (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ipratropium Bromide

Brand Name : Ipvent 40 Hfa

Dosage Form : INH

Dosage Strength : 40µg

Packaging : 200X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

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