Azelastine Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Azelastine Hydrochloride
South Africa

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Azelastine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 14 USDMF, 7 CEP/COS, 2 JDMF, 4 EU WC, 14 KDMF, 13 NDC API, 11 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

84 FDF Dossiers, 39 FDA Orange Book, 27 Europe, 3 Canada, 3 South Africa, 12 Listed Dossiers

84 FDF Dossiers
39 FDA Orange Book
27 Europe
3 Canada
3 South Africa
12 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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

3 Rochem International Inc, 3 SPI Pharma, 1 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 8 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 11 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 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, 3 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 23 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 18 Film Formers & Plasticizers, 17 Thickeners and Stabilizers, 16 Solubilizers, 16 Direct Compression, 14 Parenteral, 10 Taste Masking, 10 Co-Processed Excipients, 7 Disintegrants & Superdisintegrants, 7 Granulation, 6 Rheology Modifiers, 5 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 4 Topical, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 2 Lubricants & Glidants, 1 Soft Gelatin

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

DIGITAL CONTENT

35 NEWS #PharmaBuzz

35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Finished Drug Prices, 2 Annual Reports

1 US Medicaid Prescriptions
20 Finished Drug Prices
2 Annual Reports

MARKET PLACE

16 APIs, 1 FDF Dossiers

16 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents

14 US Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 13 Others

4 EDQM
4 USP
13 Others

$ API Ref.Price (USD/KG) : 8,541 Xls

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01 2Mylan (Pty) Ltd

02 1Viatris Healthcare (Pty) Ltd

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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 Eye Drops

03 1Rhinolast Nasal Spray

Coral Drugs Azelastine Hydrochloride

List of Suppliers

Product Main Page

01

Mylan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Mylan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Azelastine Hydrochloride

Brand Name : Optilast Eye Drops

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

02

Mylan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Mylan (Pty) Ltd

Medlab Asia & Asia Health

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

03

Viatris Healthcare (Pty) Ltd

Country

Medlab Asia & Asia Health

Not Confirmed

Viatris Healthcare (Pty) Ltd

Country

Medlab Asia & Asia Health

Not Confirmed

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Country

Virtual Booth

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

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