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Azelastine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

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

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

86 FDF Dossiers, 39 FDA Orange Book, 27 Europe, 3 Canada, 3 South Africa, 14 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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 35 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

16 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

13 US Patents

13 US Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 13 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Coral Drugs Private Limited	India	CORAL DRUGS PRIVATE LTD	36205	AZELASTINE HYDROCHLORIDE USP	2021-10-09	Active	II	Complete	2023-11-01	2023-09-22
28/03/2025	Evonik	Germany	EVONIK OPERATIONS GMBH	15440	AZELASTINE HYDROCHLORIDE	2001-05-15	Active	II	N/A

Azelastine Hydrochloride

Azelastine Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers

14 USDMF

7 CEP/COS

2 JDMF

4 EU WC

12 KDMF

14 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

86 FDF Dossiers

39 FDA Orange Book

27 Europe

3 Canada

3 South Africa

14 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**

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 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

22 Fillers, Diluents & Binders

21 Controlled & Modified Release

19 Thickeners and Stabilizers

18 Film Formers & Plasticizers

16 Solubilizers

15 Parenteral

11 Direct Compression

10 Taste Masking

SPRAY, METERED;NASAL - 0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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