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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.
A Azelastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelastine, including repackagers and relabelers. The FDA regulates Azelastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelastine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azelastine supplier is an individual or a company that provides Azelastine active pharmaceutical ingredient (API) or Azelastine finished formulations upon request. The Azelastine suppliers may include Azelastine API manufacturers, exporters, distributors and traders.
click here to find a list of Azelastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azelastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Azelastine active pharmaceutical ingredient (API) in detail. Different forms of Azelastine DMFs exist exist since differing nations have different regulations, such as Azelastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azelastine DMF submitted to regulatory agencies in the US is known as a USDMF. Azelastine USDMF includes data on Azelastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azelastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azelastine suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Azelastine Drug Master File in Japan (Azelastine JDMF) empowers Azelastine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Azelastine JDMF during the approval evaluation for pharmaceutical products. At the time of Azelastine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Azelastine suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Azelastine Drug Master File in Korea (Azelastine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azelastine. The MFDS reviews the Azelastine KDMF as part of the drug registration process and uses the information provided in the Azelastine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azelastine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Azelastine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Azelastine suppliers with KDMF on PharmaCompass.
A Azelastine CEP of the European Pharmacopoeia monograph is often referred to as a Azelastine Certificate of Suitability (COS). The purpose of a Azelastine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Azelastine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Azelastine to their clients by showing that a Azelastine CEP has been issued for it. The manufacturer submits a Azelastine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Azelastine CEP holder for the record. Additionally, the data presented in the Azelastine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Azelastine DMF.
A Azelastine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Azelastine 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 suppliers with CEP (COS) on PharmaCompass.
A Azelastine written confirmation (Azelastine WC) is an official document issued by a regulatory agency to a Azelastine manufacturer, verifying that the manufacturing facility of a Azelastine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azelastine APIs or Azelastine finished pharmaceutical products to another nation, regulatory agencies frequently require a Azelastine WC (written confirmation) as part of the regulatory process.
click here to find a list of Azelastine suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Azelastine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azelastine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Azelastine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Azelastine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azelastine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azelastine suppliers with NDC on PharmaCompass.
Azelastine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Azelastine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Azelastine GMP manufacturer or Azelastine GMP API supplier for your needs.
A Azelastine CoA (Certificate of Analysis) is a formal document that attests to Azelastine's compliance with Azelastine specifications and serves as a tool for batch-level quality control.
Azelastine CoA mostly includes findings from lab analyses of a specific batch. For each Azelastine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Azelastine may be tested according to a variety of international standards, such as European Pharmacopoeia (Azelastine EP), Azelastine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azelastine USP).
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