Salmeterol Hydroxynaphthoate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Salmeterol Hydroxynaphthoate
South Africa

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Salmeterol Hydroxynaphthoate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 21 USDMF, 13 CEP/COS, 1 JDMF, 9 EU WC, 14 NDC API, 29 Listed Suppliers

42 API Suppliers
21 USDMF
13 CEP/COS
1 JDMF
9 EU WC
14 NDC API
29 Listed Suppliers

DEVELOPMENTS

34 Drugs in Development

34 Drugs in Development

INTERMEDIATES

12 Intermediate Suppliers

12 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

780 FDF Dossiers, 25 FDA Orange Book, 637 Europe, 12 Canada, 50 Australia, 31 South Africa, 25 Listed Dossiers

780 FDF Dossiers
25 FDA Orange Book
637 Europe
12 Canada
50 Australia
31 South Africa
25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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, 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

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
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

RELATED EXCIPIENT COMPANIES

2 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 BASF, 2 DFE Pharma, 12 Kerry, 2 Microlex e.U, 1 Pluviaendo, 1 Roquette, 1 Sigachi Industries

2 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
2 BASF
2 DFE Pharma
12 Kerry
2 Microlex e.U
1 Pluviaendo
1 Roquette
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

10 Fillers, Diluents & Binders, 9 Granulation, 7 Direct Compression, 3 Co-Processed Excipients, 2 Chewable & Orodispersible Aids, 1 Coating Systems & Additives, 1 Controlled & Modified Release, 1 Parenteral

10 Fillers, Diluents & Binders
9 Granulation
7 Direct Compression
3 Co-Processed Excipients
2 Chewable & Orodispersible Aids
1 Coating Systems & Additives
1 Controlled & Modified Release
1 Parenteral

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 82 News #PharmaBuzz

3 Data Compilation #PharmaFlow
82 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 78 Regulatory FDF Prices

10 US Medicaid Prescriptions
78 Regulatory FDF Prices

MARKET PLACE

4 APIs, 2 FDF Dossiers

4 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

58 US Patents, 71 Health Canada Patents

58 US Patents
71 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 USP, 3 Others

3 EDQM
4 USP
3 Others

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31 All

01 3Austell Laboratories (Pty) Ltd

02 9Cipla Medpro (Pty) Ltd

03 3Forrester Pharma (Pty) Ltd

04 8GlaxoSmithKline South Africa (Pty) Limited

05 4Glaxosmithkline South Africa (Pty) Ltd - Cape Town

06 4Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

31 All

01 28Salmeterol

02 3salmeterol

filter Dosage Form Reset all filters

31 All

01 11ACC

02 1CAP

03 15INH

04 1KIT

05 1POW

06 1SOL

07 1SYR

filter Brand Name Reset all filters

31 All

01 1ALLI

02 1Airflusal Forspiro 50/250

03 1Airflusal Forspiro 50/500

04 1Casorol Casometer 50/250 µg

05 1Casorol Casometer 50/500 µg

06 1Duoasma 25/125

07 1Duoasma 25/250

08 1Duoasma 25/50

09 1Foxair 25/125 Inhaler

10 1Foxair 25/50 Inhaler

11 1Foxair 50/100 Accuhaler

12 1Foxair 50/250 Accuhaler

13 1Foxair 50/500 Accuhaler

14 1Keppra 100 Mg

15 1Med-Lemon Flu & Congestion Hot Medication with Vitamin C

16 1Relenza

17 1Sereflo 25/125 HFA

18 1Sereflo 25/125 HFA (Syncrobreathe)

19 1Sereflo 25/250 HFA

20 1Sereflo 25/250 HFA (Syncrobreathe)

21 1Sereflo 25/50 HFA

22 1Sereflo 25/50 HFA (Syncrobreathe)

23 1Sereflo DPI 50/100

24 1Sereflo DPI 50/250

25 1Sereflo DPI 50/500

26 1Serevent Accuhaler

27 1Serevent Inhaler CFC-Free

28 1Spirodisc 50/100

29 1Spirodisc 50/250

30 1Spirodisc 50/500

31 1Wellvone

Inke Salmeterol Xinafoate

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01

Austell Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Spirodisc 50/100

Dosage Form : INH

Dosage Strength : 50µg

Packaging : 60X1µg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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Austell Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Spirodisc 50/250

Dosage Form : INH

Dosage Strength : 50µg

Packaging : 60X1µg

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Regulatory Info : Generic

Registration Country : South Africa

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Austell Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Spirodisc 50/500

Dosage Form : INH

Dosage Strength : 50µg

Packaging : 60X1µg

Approval Date :

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Regulatory Info : Generic

Registration Country : South Africa

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04

Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sereflo DPI 50/500

Dosage Form : ACC

Dosage Strength : 50µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sereflo DPI 50/100

Dosage Form : ACC

Dosage Strength : 50µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sereflo DPI 50/250

Dosage Form : ACC

Dosage Strength : 50µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sereflo 25/50 HFA

Dosage Form : INH

Dosage Strength : 25µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sereflo 25/125 HFA

Dosage Form : INH

Dosage Strength : 25µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sereflo 25/250 HFA

Dosage Form : INH

Dosage Strength : 25µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sereflo 25/50 HFA (Syncrobreathe)

Dosage Form : INH

Dosage Strength : 25µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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