Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Data Compilation
#PharmaFlow

Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking

Stock Recap
#PipelineProspector

Azelastine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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

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

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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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

DIGITAL CONTENT

35 NEWS #PharmaBuzz

35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

16 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents

14 US Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 13 Others

$ Xls download

Filters

Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	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
28/10/2024	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

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

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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**

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

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