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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

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01 Coral Drugs Private Limited (1)

02 Evonik (1)

03 Cipla (1)

04 Curia (1)

05 DAITO CORP (1)

06 Esteve Quimica (1)

07 Gedeon Richter (1)

08 Jiangsu Hengrui Medicine (1)

09 Korea United Pharm. Inc. (1)

10 MSN Laboratories (1)

11 Urquima S.A. Grupo Uriach (1)

12 Viatris (1)

13 Zhejiang Lepu Pharmaceutical (1)

14 Zydus Lifesciences (1)

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01 AZELASTINE HCL (1)

02 AZELASTINE HCL USP (1)

03 AZELASTINE HCl (1)

04 AZELASTINE HYDROCHLORIDE (5)

05 AZELASTINE HYDROCHLORIDE BP/PH.EUR (1)

06 AZELASTINE HYDROCHLORIDE DAITO USP (1)

07 AZELASTINE HYDROCHLORIDE USP (1)

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

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

10 AZELASTINE HYDROCHLORIDE, USP (1)

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01 China (2)

02 Germany (1)

03 Hungary (1)

04 India (4)

05 Japan (1)

06 South Korea (1)

07 Spain (2)

08 U.S.A (2)

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01 Active (11)

02 Inactive (3)

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01 Complete (7)

02 Blank (7)

URL Supplier Web Content
19422
Active
2006-05-05
Complete
2014-01-27
2014-01-16
II
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18398
Active
2005-06-01
Complete
2013-09-10
2013-08-29
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22427
Active
2009-01-20
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2013-11-20
2013-11-14
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15361
Active
2001-03-29
Complete
2015-02-25
2015-02-18
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24317
Active
2010-09-28
N/A
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25356
Active
2011-10-04
Complete
2013-05-06
2012-12-07
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20314
Active
2007-02-12
Complete
2013-05-21
2013-05-10
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22919
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2009-07-02
N/A
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Looking for 79307-93-0 / Azelastine Hydrochloride API manufacturers, exporters & distributors?

Azelastine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Azelastine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Azelastine Hydrochloride manufacturer or Azelastine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azelastine Hydrochloride manufacturer or Azelastine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Azelastine Hydrochloride API Price utilized in the formulation of products. Azelastine Hydrochloride API Price is not always fixed or binding as the Azelastine Hydrochloride Price is obtained through a variety of data sources. The Azelastine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Azelastine Hydrochloride

Synonyms

Azelastine hcl, 79307-93-0, Optivar, Astelin, Allergodil, Rhinolast

Cas Number

79307-93-0

Unique Ingredient Identifier (UNII)

0L591QR10I

About Azelastine Hydrochloride

Azelastine Hydrochloride is the hydrochloride salt form of azelastine, a phthalazinone derivative with antihistaminergic activity. Azelastine hydrochloride competes with histamine for the H1 receptor, thereby diminishing the actions of histamine on effector cells and decreasing the histamine-mediated symptoms of allergic reaction, such as bronchoconstriction, vasodilation, increased capillary permeability and spasmodic contractions of gastrointestinal smooth muscle.

Azelastine Hydrochloride Manufacturers

A Azelastine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelastine Hydrochloride, including repackagers and relabelers. The FDA regulates Azelastine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelastine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Azelastine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Azelastine Hydrochloride Suppliers

A Azelastine Hydrochloride supplier is an individual or a company that provides Azelastine Hydrochloride active pharmaceutical ingredient (API) or Azelastine Hydrochloride finished formulations upon request. The Azelastine Hydrochloride suppliers may include Azelastine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Azelastine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Azelastine Hydrochloride USDMF

A Azelastine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Azelastine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Azelastine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Azelastine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Azelastine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Azelastine Hydrochloride USDMF includes data on Azelastine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azelastine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Azelastine Hydrochloride suppliers with USDMF on PharmaCompass.

Azelastine Hydrochloride Manufacturers | Traders | Suppliers

Azelastine Hydrochloride Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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