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Drug Approvals by the Medicines Control Council in South Africa containing Azelastine. Original Data : South African Medicines Price Registry

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Product

Azelastine
South Africa

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Azelastine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 14 USDMF, 6 CEP/COS, 2 JDMF, 4 EU WC, 14 KDMF, 13 NDC API, 11 Listed Suppliers, $ API Reference Price

24 API Suppliers
14 USDMF
6 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

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

2 API Suppliers

2 API 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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 8 Gangwal Healthcare, 4 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, 16 Parenteral, 10 Co-Processed Excipients, 10 Taste Masking, 7 Disintegrants & Superdisintegrants, 7 Granulation, 6 Rheology Modifiers, 5 Empty Capsules, 5 Chewable & Orodispersible Aids, 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
16 Parenteral
10 Co-Processed Excipients
10 Taste Masking
7 Disintegrants & Superdisintegrants
7 Granulation
6 Rheology Modifiers
5 Empty Capsules
5 Chewable & Orodispersible Aids
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

15 APIs, 1 FDF Dossiers

15 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) : 8,534 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

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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

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Mylan (Pty) Ltd

FNCE 2024

Not Confirmed

Mylan (Pty) Ltd

FNCE 2024

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

FNCE 2024

Not Confirmed

Mylan (Pty) Ltd

FNCE 2024

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

FNCE 2024

Not Confirmed

Viatris Healthcare (Pty) Ltd

Country

FNCE 2024

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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