Afluon | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Afluon
South Africa

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Afluon

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 14 USDMF, 7 CEP/COS, 2 JDMF, 4 EU WC, 12 KDMF, 14 NDC API, 13 Listed Suppliers, $ API Reference Price

38 API Suppliers
14 USDMF
7 CEP/COS
2 JDMF
4 EU WC
12 KDMF
14 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

92 FDF Dossiers, 40 FDA Orange Book, 27 Europe, 3 Canada, 3 South Africa, 19 Listed Dossiers

92 FDF Dossiers
40 FDA Orange Book
27 Europe
3 Canada
3 South Africa
19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 3 SPI Pharma, 4 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 11 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 15 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 12 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 1 Silverline Chemicals, 3 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 22 Fillers, Diluents & Binders, 21 Controlled & Modified Release, 19 Thickeners and Stabilizers, 18 Film Formers & Plasticizers, 16 Solubilizers, 15 Parenteral, 12 Co-Processed Excipients, 11 Direct Compression, 10 Taste Masking, 9 Rheology Modifiers, 7 Granulation, 6 Disintegrants & Superdisintegrants, 5 Topical, 5 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Coloring Agents, 2 Surfactant & Foaming Agents, 1 Lubricants & Glidants, 1 Soft Gelatin

45 Coating Systems & Additives
22 Fillers, Diluents & Binders
21 Controlled & Modified Release
19 Thickeners and Stabilizers
18 Film Formers & Plasticizers
16 Solubilizers
15 Parenteral
12 Co-Processed Excipients
11 Direct Compression
10 Taste Masking
9 Rheology Modifiers
7 Granulation
6 Disintegrants & Superdisintegrants
5 Topical
5 Chewable & Orodispersible Aids
5 Empty Capsules
4 Emulsifying Agents
4 Vegetarian Capsules
4 API Stability Enhancers
2 Coloring Agents
2 Surfactant & Foaming Agents
1 Lubricants & Glidants
1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 35 News #PharmaBuzz

1 Data Compilation #PharmaFlow
35 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Regulatory FDF Prices, 3 Annual Reports

1 US Medicaid Prescriptions
20 Regulatory FDF Prices
3 Annual Reports

MARKET PLACE

16 APIs, 1 FDF Dossiers

16 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

13 US Patents

13 US Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 13 Others

4 EDQM
13 Others

$ API Ref.Price (USD/KG) : 7,326 Xls

Filters

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3 All

01 1Mylan (Pty) Ltd

02 1Viatris

03 1Viatris Healthcare (Pty) Ltd

filter Active Ingredients Reset all filters

3 All

01 3Azelastine Hydrochloride

filter Dosage Form Reset all filters

3 All

01 1DRP

02 1NAS

03 1SPR

filter Brand Name Reset all filters

3 All

01 1Dymista Nasal Spray

02 1Optilast

03 1Rhinolast Nasal Spray

Coral Drugs Azelastine Hydrochloride

List of Suppliers

Product Main Page

01

Mylan (Pty) Ltd

ACS GCI

Not Confirmed

Mylan (Pty) Ltd

ACS GCI

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Azelastine Hydrochloride

Brand Name : Rhinolast Nasal Spray

Dosage Form : SPR

Dosage Strength : 0.14mg/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Viatris

ACS GCI

Not Confirmed

Viatris

ACS GCI

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Azelastine Hydrochloride

Brand Name : Optilast

Dosage Form : DRP

Dosage Strength : 0.5mg/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Viatris Healthcare (Pty) Ltd

Country

ACS GCI

Not Confirmed

Viatris Healthcare (Pty) Ltd

Country

ACS GCI

Not Confirmed

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Country

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Azelastine Hydrochloride

Brand Name : Dymista Nasal Spray

Dosage Form : NAS

Dosage Strength : 137µg/spray

Packaging : 120X1µg/spray

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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