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List of Certificates of Suitability (CEPs) for Azelastine HCl Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

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R0-CEP 2011-081 - Rev 01
Withdrawn by Holder
Chemical
2014-07-28
2016-08-17
1633
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R1-CEP 2010-010 - Rev 03
Valid
Chemical
2020-08-17
1633
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R1-CEP 2011-363 - Rev 01
Valid
Chemical
2022-06-01
1633
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R1-CEP 2007-097 - Rev 02
Valid
Chemical
2021-06-16
1633
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EVONIK OPERATIONS GMBH Essen DE

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CEP 2009-333 - Rev 05
Valid
Chemical
2024-04-24
1633
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R0-CEP 2019-018 - Rev 02
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2022-07-11
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  • SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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  • SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 HCl Manufacturers

A Azelastine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelastine HCl, including repackagers and relabelers. The FDA regulates Azelastine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelastine HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Azelastine HCl Suppliers

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

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

Azelastine HCl CEP

A Azelastine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Azelastine HCl Certificate of Suitability (COS). The purpose of a Azelastine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Azelastine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Azelastine HCl to their clients by showing that a Azelastine HCl CEP has been issued for it. The manufacturer submits a Azelastine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Azelastine HCl CEP holder for the record. Additionally, the data presented in the Azelastine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Azelastine HCl DMF.

A Azelastine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Azelastine HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Azelastine HCl suppliers with CEP (COS) on PharmaCompass.

Azelastine HCl Manufacturers | Traders | Suppliers

Azelastine HCl Manufacturers, Traders, Suppliers 1
43

We have 6 companies offering Azelastine HCl

Get in contact with the supplier of your choice:

  1. Coral Drugs Private Limited
  2. Cipla
  3. Esteve Quimica
  4. MSN Laboratories
  5. Urquima S.A. Grupo Uriach
  6. Zydus Lifesciences
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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