Budesonide 21-acetate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Budesonide 21-acetate
South Africa

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Budesonide 21-acetate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

67 API Suppliers, 24 USDMF, 28 CEP/COS, 7 JDMF, 7 EU WC, 15 KDMF, 34 NDC API, 43 Listed Suppliers, $ API Reference Price

67 API Suppliers
24 USDMF
28 CEP/COS
7 JDMF
7 EU WC
15 KDMF
34 NDC API
43 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

71 Drugs in Development

71 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

611 FDF Dossiers, 54 FDA Orange Book, 429 Europe, 23 Canada, 13 Australia, 39 South Africa, 53 Listed Dossiers

611 FDF Dossiers
54 FDA Orange Book
429 Europe
23 Canada
13 Australia
39 South Africa
53 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 9MG, AEROSOL, FOAM;RECTAL - 2MG/ACTUATION, SPRAY, METERED;NASAL - 0.032MG/SPRAY, SUSPENSION;INHALATION - 0.25MG/2ML, SUSPENSION;INHALATION - 0.5MG/2ML, SUSPENSION;INHALATION - 1MG/2ML, CAPSULE, DELAYED RELEASE;ORAL - 6MG, CAPSULE, DELAYED RELEASE;ORAL - 9MG, CAPSULE, DELAYED RELEASE;ORAL - 3MG, AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH, AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

TABLET, EXTENDED RELEASE;ORAL - 9MG
AEROSOL, FOAM;RECTAL - 2MG/ACTUATION
SPRAY, METERED;NASAL - 0.032MG/SPRAY
SUSPENSION;INHALATION - 0.25MG/2ML
SUSPENSION;INHALATION - 0.5MG/2ML
SUSPENSION;INHALATION - 1MG/2ML
CAPSULE, DELAYED RELEASE;ORAL - 6MG
CAPSULE, DELAYED RELEASE;ORAL - 9MG
CAPSULE, DELAYED RELEASE;ORAL - 3MG
AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH
AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

RELATED EXCIPIENT COMPANIES

1 Evonik, 1 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 9 DKSH, 1 Jai Radhe Sales, 4 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Clariant, 14 Corel Pharma Chem, 4 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 31 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 14 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 4 The Dow Chemical Company, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

67 Coating Systems & Additives, 67 Fillers, Diluents & Binders, 41 Controlled & Modified Release, 33 Thickeners and Stabilizers, 30 Direct Compression, 24 Solubilizers, 20 Film Formers & Plasticizers, 20 Granulation, 19 Lubricants & Glidants, 19 Taste Masking, 18 Topical, 15 Parenteral, 15 Co-Processed Excipients, 11 Disintegrants & Superdisintegrants, 9 Emulsifying Agents, 9 Empty Capsules, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

67 Coating Systems & Additives
67 Fillers, Diluents & Binders
41 Controlled & Modified Release
33 Thickeners and Stabilizers
30 Direct Compression
24 Solubilizers
20 Film Formers & Plasticizers
20 Granulation
19 Lubricants & Glidants
19 Taste Masking
18 Topical
15 Parenteral
15 Co-Processed Excipients
11 Disintegrants & Superdisintegrants
9 Emulsifying Agents
9 Empty Capsules
6 Rheology Modifiers
6 Chewable & Orodispersible Aids
5 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 129 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
129 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 232 Finished Drug Prices, 37 Annual Reports

5 US Medicaid Prescriptions
232 Finished Drug Prices
37 Annual Reports

MARKET PLACE

18 APIs, 17 FDF Dossiers, 1 EXCIPIENTS

18 APIs
17 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

53 US Patents, 5 US Exclusivities, 2 Health Canada Patents

53 US Patents
5 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 13 Others

2 EDQM
4 USP
13 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 3,434 Xls

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39 All

01 7Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

02 6Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

03 7Cipla Medpro (Pty) Ltd

04 2Equity Pharmaceuticals (Pty) Ltd

05 2Forrester Pharma (Pty) Ltd

06 8Ingelheim Pharmaceuticals (Pty) Ltd

07 2Ranbaxy Pharmaceuticals (Pty) Ltd

08 1Specpharm (Pty) Ltd

09 4Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

39 All

01 2BUDESONIDE

02 37Budesonide

filter Dosage Form Reset all filters

39 All

01 6AQS

02 2CAP

03 1CPS

04 1ENS

05 18INH

06 1NAS

07 2REF

08 2SLN

09 6SUS

filter Brand Name Reset all filters

39 All

01 1Aeromide

02 1Aeromide Nasal 100

03 1Arrow Budesonide 0.25mg/ml

04 1Arrow Budesonide 0.5mg/ml

05 1BUDAIR 0,25 mg/ml

06 1BUDAIR 0,5 mg/ml

07 1Budeflam

08 1Budeflam 200

09 1Budeflam 200 Dp-Caps

10 2Budeflam 300Dose Hfa

11 1Budeflam Aquanase

12 1Budenofalk 3 mg

13 1Budoneb 0.25mg/ml

14 1Budoneb 0.5mg/ml

15 1Entocord 3 mg

16 1Entocord 0.02 mg/ml

17 1Inflammide 200 Novolizer

18 1Inflammide 100

19 1Inflammide 200

20 1Inflammide 200 Novolizer

21 2Inflammide 400 Novolizer

22 1Inflanaze 100

23 1Inflanaze 50

24 1Pulmicort Turbuhaler 100 µg/Dose

25 1Pulmicort Nebuliser Suspension

26 1Pulmicort Nebulliser Suspension

27 1Pulmicort Turbuhaler 200 µg/Dose

28 1Pulmicort Turbuhaler 400 µg/Dose

29 2Rhinocort Aqua 120 Doses 10Mls

30 1Spec-Budesonide 100

31 3Symbicord Turbuhaler 160:4,5µg / dose

32 1Symbicord Turbuhaler 320:9µg / dose

33 1Vannair 160:4,5

34 1Vannair 80:4,5

Minakem Budesonide

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01

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Rhinocort Aqua 120 Doses 10Mls

Dosage Form : AQS

Dosage Strength : 64mcg

Packaging : 120X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Rhinocort Aqua 120 Doses 10Mls

Dosage Form : AQS

Dosage Strength : 32mcg

Packaging : 120X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pulmicort Turbuhaler 100 µg/Dose

Dosage Form : INH

Dosage Strength : 100mcg

Packaging : 200X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pulmicort Turbuhaler 200 µg/Dose

Dosage Form : INH

Dosage Strength : 200mcg

Packaging : 200X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pulmicort Nebulliser Suspension

Dosage Form : SLN

Dosage Strength : 5mg

Packaging : 20X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pulmicort Turbuhaler 400 µg/Dose

Dosage Form : INH

Dosage Strength : 400mcg

Packaging : 100X1mcg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pulmicort Nebuliser Suspension

Dosage Form : SLN

Dosage Strength : 1mg

Packaging : 20X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Symbicord Turbuhaler 160:4,5µg / dose

Dosage Form : INH

Dosage Strength : 160µg

Packaging : 60X1µg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Symbicord Turbuhaler 160:4,5µg / dose

Dosage Form : INH

Dosage Strength : 160µg

Packaging : 120X1µg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Astrazeneca Pharmaceuticals (Pty) Ltd- B...

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Symbicord Turbuhaler 320:9µg / dose

Dosage Form : INH

Dosage Strength : 320µg

Packaging : 60X1µg

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Regulatory Info : Originator

Registration Country : South Africa

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