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List of Drug Master Files (DMF) of Azelastine Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Azelastine Hydrochloride
USDMF

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

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Azelastine Hydrochloride

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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Filters

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14 All

01 1Coral Drugs Private Limited

02 1Evonik

03 1Cipla

04 1Curia

05 1DAITO CORP

06 1Esteve Quimica

07 1Gedeon Richter

08 1Jiangsu Hengrui Medicine

09 1Korea United Pharm. Inc.

10 1MSN Laboratories

11 1Urquima S.A. Grupo Uriach

12 1Viatris

13 1Zhejiang Lepu Pharmaceutical

14 1Zydus Lifesciences

filter Subject Reset all filters

14 All

01 1AZELASTINE HCL

02 1AZELASTINE HCL USP

03 1AZELASTINE HCl

04 5AZELASTINE HYDROCHLORIDE

05 1AZELASTINE HYDROCHLORIDE BP/PH.EUR

06 1AZELASTINE HYDROCHLORIDE DAITO USP

07 1AZELASTINE HYDROCHLORIDE USP

08 1AZELASTINE HYDROCHLORIDE USP [ROUTE CODE - "AH"]

09 1AZELASTINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

10 1AZELASTINE HYDROCHLORIDE, USP

filter Country Reset all filters

14 All

01 2China

02 1Germany

03 1Hungary

04 4India

05 1Japan

06 1South Korea

07 2Spain

08 2U.S.A

filter Status Reset all filters

14 All

01 11Active

02 3Inactive

filter GDUFA DMF Review Reset all filters

14 All

01 7Complete

02 7Blank

Coral Drugs Azelastine Hydrochloride

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Coral Drugs Private Ltd

CPhI Worldwide, Milan

Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.

Contact Supplier

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Digital Content

Azelastine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2023-11-01

Pay. Date : 2023-09-22

DMF Number : 36205

Submission : 2021-10-09

Status : Active

Type : II

Corel Drugs cGMP partner for APIs

Product Web Link

Digital Content

02

Evonik Operations Gmbh

CPhI Worldwide, Milan

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

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Contact Supplier

Digital Content

Azelastine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15440

Submission : 2001-05-15

Status : Active

Type : II

Evonik company banner

Product Web Link

Digital Content

03

Curia Italy Srl

USDMF

Luxepack

Not Confirmed

03

Curia Italy Srl

Luxepack

Not Confirmed

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Digital Content

Azelastine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-27

Pay. Date : 2014-01-16

DMF Number : 19422

Submission : 2006-05-05

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

04

Daito Pharmaceutical Co Ltd

USDMF

Luxepack

Not Confirmed

04

Daito Pharmaceutical Co Ltd

Luxepack

Not Confirmed

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Digital Content

Azelastine Hydrochloride Daito Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-10

Pay. Date : 2013-08-29

DMF Number : 18398

Submission : 2005-06-01

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Esteve Quimica Sa

USDMF

Luxepack

Not Confirmed

05

Esteve Quimica Sa

Luxepack

Not Confirmed

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Digital Content

Azelastine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-20

Pay. Date : 2013-11-14

DMF Number : 22427

Submission : 2009-01-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Gedeon Richter Plc

USDMF

Luxepack

Not Confirmed

06

Gedeon Richter Plc

Luxepack

Not Confirmed

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Digital Content

Azelastine Hcl Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-25

Pay. Date : 2015-02-18

DMF Number : 15361

Submission : 2001-03-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Korea United Pharmaceuticals Inc

USDMF

Luxepack

Not Confirmed

07

Korea United Pharmaceuticals Inc

Luxepack

Not Confirmed

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Digital Content

Azelastine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24317

Submission : 2010-09-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Msn Laboratories Private Ltd

USDMF

Luxepack

Not Confirmed

08

Msn Laboratories Private Ltd

Luxepack

Not Confirmed

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Digital Content

Azelastine Hydrochloride Usp [route Code - "ah...

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-06

Pay. Date : 2012-12-07

DMF Number : 25356

Submission : 2011-10-04

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Urquima Sa

USDMF

Luxepack

Not Confirmed

09

Urquima Sa

Luxepack

Not Confirmed

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Digital Content

Azelastine Hcl

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-21

Pay. Date : 2013-05-10

DMF Number : 20314

Submission : 2007-02-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zydus Lifesciences Ltd

USDMF

Luxepack

Not Confirmed

10

Zydus Lifesciences Ltd

Luxepack

Not Confirmed

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.

Post an Enquiry

Post an Enquiry

Digital Content

Azelastine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 22919

Submission : 2009-07-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Azelastine Hydrochloride Manufacturers | Traders | Suppliers

Azelastine Hydrochloride Manufacturers, Traders, Suppliers 1

40

We have 14 companies offering Azelastine Hydrochloride

Get in contact with the supplier of your choice:

Evonik
Coral Drugs Private Limited
Cipla
Curia
DAITO CORP
Esteve Quimica
Gedeon Richter
Jiangsu Hengrui Medicine
Korea United Pharm. Inc.
MSN Laboratories
Urquima S.A. Grupo Uriach
Viatris
Zhejiang Lepu Pharmaceutical
Zydus Lifesciences

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