Formoterol Fumarate Dihydrate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Formoterol Fumarate Dihydrate
South Africa

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Formoterol Fumarate Dihydrate

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 15 USDMF, 14 CEP/COS, 4 JDMF, 8 EU WC, 12 KDMF, 21 NDC API, 26 Listed Suppliers, $ API Reference Price

35 API Suppliers
15 USDMF
14 CEP/COS
4 JDMF
8 EU WC
12 KDMF
21 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

319 FDF Dossiers, 21 FDA Orange Book, 243 Europe, 8 Canada, 3 Australia, 11 South Africa, 33 Listed Dossiers

319 FDF Dossiers
21 FDA Orange Book
243 Europe
8 Canada
3 Australia
11 South Africa
33 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH, AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH, AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH, AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH, AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH, AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH
AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH
AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH
AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH
AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH
AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

RELATED EXCIPIENT COMPANIES

2 Nanjing Well Pharmaceutical, 5 Actylis, 2 BASF, 1 Clariant, 1 Finar, 3 Kerry, 1 Microlex e.U, 1 Nippon Fine Chemical, 1 Roquette

2 Nanjing Well Pharmaceutical
5 Actylis
2 BASF
1 Clariant
1 Finar
3 Kerry
1 Microlex e.U
1 Nippon Fine Chemical
1 Roquette

EXCIPIENTS BY APPLICATIONS

5 Parenteral, 3 Topical, 3 Controlled & Modified Release, 3 Co-Processed Excipients, 2 Fillers, Diluents & Binders, 2 Granulation, 2 Direct Compression, 2 Emulsifying Agents, 1 Coating Systems & Additives, 1 Thickeners and Stabilizers, 1 Solubilizers, 1 Dry Powder Inhalation, 1 Film Formers & Plasticizers, 1 Lubricants & Glidants, 1 Surfactant & Foaming Agents

5 Parenteral
3 Topical
3 Controlled & Modified Release
3 Co-Processed Excipients
2 Fillers, Diluents & Binders
2 Granulation
2 Direct Compression
2 Emulsifying Agents
1 Coating Systems & Additives
1 Thickeners and Stabilizers
1 Solubilizers
1 Dry Powder Inhalation
1 Film Formers & Plasticizers
1 Lubricants & Glidants
1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 64 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
64 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 193 Finished Drug Prices, 32 Annual Reports

2 US Medicaid Prescriptions
193 Finished Drug Prices
32 Annual Reports

MARKET PLACE

12 APIs

12 APIs

PATENTS & EXCLUSIVITIES

40 US Patents

40 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 8 Others

3 EDQM
3 USP
8 Others

$ API Ref.Price (USD/KG) : 133,376 Xls

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11 All

01 2Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

02 2Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

03 2Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

04 2Cipla Medpro (Pty) Ltd

05 1Novartis South Africa (Pty) Ltd

06 2Organon South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

11 All

01 3Formoterol

02 4Formoterol Fumarate

03 2Formoterol Fumarate Dihydrate

04 2Formoterol Fumarate Dihyrate

filter Dosage Form Reset all filters

11 All

01 2CPS

02 8INH

03 1TAB

filter Brand Name Reset all filters

11 All

01 2Bricanyl Turbuhaler 0.5mg/dose

02 1Dulera Inhaler 100/5 µg

03 1Dulera Inhaler 200/5 µg

04 1Foradil

05 1Foratec DP-Caps

06 1Foratec HFA

07 1Oxis Turbuhaler 9 60 Dose

08 1Seroquel

09 1Vannair 160:4,5

10 1Vannair 80:4,5

Formoterol Fumarate

List of Suppliers

Product Main Page

01

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Formoterol Fumarate Dihyrate

Brand Name : Bricanyl Turbuhaler 0.5mg/dose

Dosage Form : INH

Dosage Strength : 80mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Formoterol Fumarate Dihyrate

Brand Name : Bricanyl Turbuhaler 0.5mg/dose

Dosage Form : INH

Dosage Strength : 80mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Seroquel

Dosage Form : TAB

Dosage Strength : 9mcg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

CPhI India 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Oxis Turbuhaler 9 60 Dose

Dosage Form : INH

Dosage Strength : 9mcg

Packaging : 60X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

CPhI India 2024

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

CPhI India 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Formoterol Fumarate

Brand Name : Vannair 80:4,5

Dosage Form : INH

Dosage Strength : 80µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

CPhI India 2024

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

CPhI India 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Formoterol Fumarate

Brand Name : Vannair 160:4,5

Dosage Form : INH

Dosage Strength : 160µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Cipla Medpro (Pty) Ltd

CPhI India 2024

Not Confirmed

Cipla Medpro (Pty) Ltd

CPhI India 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Formoterol Fumarate

Brand Name : Foratec HFA

Dosage Form : INH

Dosage Strength : 12mcg

Packaging : 120X1mcg

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

CPhI India 2024

Not Confirmed

Cipla Medpro (Pty) Ltd

CPhI India 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Formoterol Fumarate

Brand Name : Foratec DP-Caps

Dosage Form : CPS

Dosage Strength : 12mcg

Packaging : 60X1mcg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Novartis South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Foradil

Dosage Form : CPS

Dosage Strength : 12mcg

Packaging : 60X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Organon South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

Organon South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Formoterol Fumarate Dihydrate

Brand Name : Dulera Inhaler 200/5 µg

Dosage Form : INH

Dosage Strength : 5mcg

Packaging : 120X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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