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ABOUT THIS PAGE
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PharmaCompass offers a list of Ebastine 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 Ebastine manufacturer or Ebastine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ebastine manufacturer or Ebastine supplier.
PharmaCompass also assists you with knowing the Ebastine API Price utilized in the formulation of products. Ebastine API Price is not always fixed or binding as the Ebastine Price is obtained through a variety of data sources. The Ebastine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ebastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ebastine, including repackagers and relabelers. The FDA regulates Ebastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ebastine 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 Ebastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ebastine supplier is an individual or a company that provides Ebastine active pharmaceutical ingredient (API) or Ebastine finished formulations upon request. The Ebastine suppliers may include Ebastine API manufacturers, exporters, distributors and traders.
click here to find a list of Ebastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Ebastine Drug Master File in Japan (Ebastine JDMF) empowers Ebastine 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 Ebastine JDMF during the approval evaluation for pharmaceutical products. At the time of Ebastine 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 Ebastine 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 Ebastine Drug Master File in Korea (Ebastine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ebastine. The MFDS reviews the Ebastine KDMF as part of the drug registration process and uses the information provided in the Ebastine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ebastine 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 Ebastine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ebastine suppliers with KDMF on PharmaCompass.
A Ebastine CEP of the European Pharmacopoeia monograph is often referred to as a Ebastine Certificate of Suitability (COS). The purpose of a Ebastine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ebastine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ebastine to their clients by showing that a Ebastine CEP has been issued for it. The manufacturer submits a Ebastine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ebastine CEP holder for the record. Additionally, the data presented in the Ebastine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ebastine DMF.
A Ebastine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ebastine 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 Ebastine suppliers with CEP (COS) on PharmaCompass.
A Ebastine written confirmation (Ebastine WC) is an official document issued by a regulatory agency to a Ebastine manufacturer, verifying that the manufacturing facility of a Ebastine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ebastine APIs or Ebastine finished pharmaceutical products to another nation, regulatory agencies frequently require a Ebastine WC (written confirmation) as part of the regulatory process.
click here to find a list of Ebastine suppliers with Written Confirmation (WC) on PharmaCompass.
Ebastine 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 Ebastine 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 Ebastine GMP manufacturer or Ebastine GMP API supplier for your needs.
A Ebastine CoA (Certificate of Analysis) is a formal document that attests to Ebastine's compliance with Ebastine specifications and serves as a tool for batch-level quality control.
Ebastine CoA mostly includes findings from lab analyses of a specific batch. For each Ebastine 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.
Ebastine may be tested according to a variety of international standards, such as European Pharmacopoeia (Ebastine EP), Ebastine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ebastine USP).
