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Approved Drug Products containing Azelastine Hydrochloride listed with Health Canada. Original Data : Health Canada Website

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Product

Azelastine Hydrochloride
Canada

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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 Hydrochloride

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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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3 All

01 1APOTEX INC

02 1BGP PHARMA ULC

03 1MYLAN PHARMACEUTICALS ULC

filter Active Ingredients Reset all filters

3 All

01 3AZELASTINE HYDROCHLORIDE

filter Dosage Form Reset all filters

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01 3SPRAY, METERED DOSE

filter Brand Name Reset all filters

3 All

01 1APO-AZELASTINE/FLUTICASONE

02 1DYMISTA

03 1MYLAN-AZELASTINE/FLUTICASONE

Coral Drugs Azelastine Hydrochloride

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

APOTEX INC

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APOTEX INC

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

AZELASTINE HYDROCHLORIDE

Brand Name : APO-AZELASTINE/FLUTICASONE

Dosage Form : SPRAY, METERED DOSE

Dosage Strength : 137MCG/ACT

Packaging :

Approval Date :

Application Number : 2540886

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

BGP PHARMA ULC

Discovery on Target

Not Confirmed

BGP PHARMA ULC

Discovery on Target

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

AZELASTINE HYDROCHLORIDE

Brand Name : DYMISTA

Dosage Form : SPRAY, METERED DOSE

Dosage Strength : 137MCG/ACT

Packaging : 28/120 ACT

Approval Date :

Application Number : 2432889

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

MYLAN PHARMACEUTICALS ULC

Discovery on Target

Not Confirmed

MYLAN PHARMACEUTICALS ULC

Discovery on Target

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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

AZELASTINE HYDROCHLORIDE

Brand Name : MYLAN-AZELASTINE/FLUTICASONE

Dosage Form : SPRAY, METERED DOSE

Dosage Strength : 137MCG/ACT

Packaging :

Approval Date :

Application Number : 2530341

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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