Fluticasone Propionate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Fluticasone Propionate
South Africa

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Fluticasone Propionate

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ACTIVE PHARMA INGREDIENTS

68 API Suppliers, 29 USDMF, 30 CEP/COS, 6 JDMF, 7 EU WC, 2 KDMF, 27 NDC API, 43 Listed Suppliers, $ API Reference Price

68 API Suppliers
29 USDMF
30 CEP/COS
6 JDMF
7 EU WC
2 KDMF
27 NDC API
43 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

47 Drugs in Development

47 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

429 FDF Dossiers, 70 FDA Orange Book, 212 Europe, 32 Canada, 13 Australia, 51 South Africa, 51 Listed Dossiers

429 FDF Dossiers
70 FDA Orange Book
212 Europe
32 Canada
13 Australia
51 South Africa
51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SPRAY, METERED;NASAL - 0.05MG/SPRAY, POWDER;INHALATION - 0.05MG/INH, POWDER;INHALATION - 0.1MG/INH, POWDER;INHALATION - 0.25MG/INH, POWDER;INHALATION - 0.03MG/INH, POWDER;INHALATION - 0.055MG/INH, POWDER;INHALATION - 0.113MG/INH, POWDER;INHALATION - 0.232MG/INH, POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH, POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH, POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH, LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.044MG/INH, AEROSOL, METERED;INHALATION - 0.11MG/INH, AEROSOL, METERED;INHALATION - 0.22MG/INH

OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
SPRAY, METERED;NASAL - 0.05MG/SPRAY
POWDER;INHALATION - 0.05MG/INH
POWDER;INHALATION - 0.1MG/INH
POWDER;INHALATION - 0.25MG/INH
POWDER;INHALATION - 0.03MG/INH
POWDER;INHALATION - 0.055MG/INH
POWDER;INHALATION - 0.113MG/INH
POWDER;INHALATION - 0.232MG/INH
POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH
POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH
POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH
POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH
POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH
POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH
LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH
AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH
AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH
AEROSOL, METERED;INHALATION - 0.044MG/INH
AEROSOL, METERED;INHALATION - 0.11MG/INH
AEROSOL, METERED;INHALATION - 0.22MG/INH

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 2 SPI Pharma, 1 DKSH, 2 Jai Radhe Sales, 2 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 10 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 5 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 20 Kerry, 1 Kima Chemical, 10 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 10 Roquette, 8 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 1 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

1 Rochem International Inc
2 SPI Pharma
1 DKSH
2 Jai Radhe Sales
2 Faran Shimi Pharmaceutical
9 Gangwal Healthcare
6 Nanjing Well Pharmaceutical
10 Actylis
3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
11 BASF
5 DFE Pharma
2 Finar
7 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
1 Ingredion Pharma Solutions
20 Kerry
1 Kima Chemical
10 Microlex e.U
1 Nanjing Bold Chemical
1 Pharmatrans-Sanaq
4 Pluviaendo
2 Prachin Chemical
10 Roquette
8 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
10 Sigachi Industries
1 The Dow Chemical Company
1 Valens Pharmachem
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

40 Fillers, Diluents & Binders, 23 Direct Compression, 21 Solubilizers, 20 Thickeners and Stabilizers, 18 Topical, 15 Disintegrants & Superdisintegrants, 14 Co-Processed Excipients, 12 Granulation, 12 Parenteral, 10 Emulsifying Agents, 10 Controlled & Modified Release, 7 Film Formers & Plasticizers, 6 Surfactant & Foaming Agents, 6 Rheology Modifiers, 6 Coating Systems & Additives, 3 Taste Masking, 2 Chewable & Orodispersible Aids, 2 Lubricants & Glidants, 1 API Stability Enhancers

40 Fillers, Diluents & Binders
23 Direct Compression
21 Solubilizers
20 Thickeners and Stabilizers
18 Topical
15 Disintegrants & Superdisintegrants
14 Co-Processed Excipients
12 Granulation
12 Parenteral
10 Emulsifying Agents
10 Controlled & Modified Release
7 Film Formers & Plasticizers
6 Surfactant & Foaming Agents
6 Rheology Modifiers
6 Coating Systems & Additives
3 Taste Masking
2 Chewable & Orodispersible Aids
2 Lubricants & Glidants
1 API Stability Enhancers

DIGITAL CONTENT

11 DATA COMPILATION #PharmaFlow, 142 NEWS #PharmaBuzz

11 DATA COMPILATION #PharmaFlow
142 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 164 Finished Drug Prices, 12 Annual Reports

4 US Medicaid Prescriptions
164 Finished Drug Prices
12 Annual Reports

MARKET PLACE

16 APIs, 4 FDF Dossiers, 1 EXCIPIENTS

16 APIs
4 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

573 US Patents, 11 US Exclusivities, 53 Health Canada Patents

573 US Patents
11 US Exclusivities
53 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 7 USP, 9 Others

4 EDQM
7 USP
9 Others

$ API Ref.Price (USD/KG) : 19,289 Xls

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51 All

01 3Austell Laboratories (Pty) Ltd

02 12Cipla Medpro (Pty) Ltd

03 3Forrester Pharma (Pty) Ltd

04 27GlaxoSmithKline South Africa (Pty) Limited

05 4Sandoz SA (Pty) Ltd

06 1Teva Pharmaceuticals (Pty) Ltd

07 1Viatris Healthcare (Pty) Ltd

filter Active Ingredients Reset all filters

51 All

01 1FLUTICASONE PROPIONATE

02 3Flucticasone Propionate

03 27Fluticasone Propionate

04 17Fluticasone Proprionate

05 3fluticasone propionate

filter Dosage Form Reset all filters

51 All

01 13ACC

02 2AQS

03 2CPS

04 2CRE

05 25INH

06 3NAS

07 1NOD

08 2OIN

09 1SPO

filter Brand Name Reset all filters

51 All

01 1Airflusal Forspiro 50/250

02 1Airflusal Forspiro 50/500

03 1Casorol Casometer 50/250 µg

04 1Casorol Casometer 50/500 µg

05 2Cutivate Cream

06 2Cutivate Ointment

07 1Duoasma 25/125

08 1Duoasma 25/250

09 1Duoasma 25/50

10 1Dymista Nasal Spray

11 1FLUTICASONE OTC TEVA

12 1Flixonase Aqueous Nasal Spray

13 1Flixonase Nasules

14 1Flixotide 100 Accuhaler

15 1Flixotide 125 Inhaler CFC - FREE

16 1Flixotide 250 Accuhaler

17 1Flixotide 250 Inhaler CFC - FREE

18 1Flixotide 50 Accuhaler

19 1Flixotide 50 Inhaler CFC - FREE

20 1Flixotide 500 Accuhaler

21 1Flohale 100 Dp-Caps

22 1Flohale 250 Dp-Caps

23 1Flomist

24 2Flonase Aqueous Nasal Spray

25 1Foxair 25/125 Inhaler

26 1Foxair 25/250 Inhaler

27 1Foxair 25/50 Inhaler

28 1Foxair 50/100 Accuhaler

29 1Foxair 50/250 Accuhaler

30 1Foxair 50/500 Accuhaler

31 1Sereflo 25/125 HFA

32 1Sereflo 25/125 HFA (Syncrobreathe)

33 1Sereflo 25/250 HFA

34 1Sereflo 25/250 HFA (Syncrobreathe)

35 1Sereflo 25/50 HFA

36 1Sereflo 25/50 HFA (Syncrobreathe)

37 1Sereflo DPI 50/100

38 1Sereflo DPI 50/250

39 1Sereflo DPI 50/500

40 1Seretide 25/125 Inhaler

41 1Seretide 25/250

42 1Seretide 25/50 Inhaler

43 1Seretide 50/100 Accuhaler

44 1Seretide 50/250 Accuhaler

45 1Seretide 50/500 Accuhaler

46 1Spirodisc 50/100

47 1Spirodisc 50/250

48 1Spirodisc 50/500

EUROAPI Fluticasone

List of Suppliers

Product Main Page

01

Austell Laboratories (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Austell Laboratories (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Spirodisc 50/100

Dosage Form : INH

Dosage Strength : 100µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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02

Austell Laboratories (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Austell Laboratories (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Spirodisc 50/250

Dosage Form : INH

Dosage Strength : 250µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

Digital Content

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03

Austell Laboratories (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Austell Laboratories (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Spirodisc 50/500

Dosage Form : INH

Dosage Strength : 500µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Sereflo DPI 50/500

Dosage Form : ACC

Dosage Strength : 500µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Sereflo DPI 50/100

Dosage Form : ACC

Dosage Strength : 100µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Sereflo DPI 50/250

Dosage Form : ACC

Dosage Strength : 250µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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07

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Flohale 100 Dp-Caps

Dosage Form : CPS

Dosage Strength : 100mcg

Packaging : 60X1mcg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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08

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Flohale 250 Dp-Caps

Dosage Form : CPS

Dosage Strength : 250mcg

Packaging : 60X1mcg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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09

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Flomist

Dosage Form : NAS

Dosage Strength : 50mcg

Packaging : 120X1mcg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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10

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Cipla Medpro (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluticasone Propionate

Brand Name : Sereflo 25/50 HFA

Dosage Form : INH

Dosage Strength : 50µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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