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A Betahistine Dimesilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine Dimesilate, including repackagers and relabelers. The FDA regulates Betahistine Dimesilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine Dimesilate 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 Betahistine Dimesilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betahistine Dimesilate supplier is an individual or a company that provides Betahistine Dimesilate active pharmaceutical ingredient (API) or Betahistine Dimesilate finished formulations upon request. The Betahistine Dimesilate suppliers may include Betahistine Dimesilate API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine Dimesilate 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 Betahistine Dimesilate Drug Master File in Japan (Betahistine Dimesilate JDMF) empowers Betahistine Dimesilate 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 Betahistine Dimesilate JDMF during the approval evaluation for pharmaceutical products. At the time of Betahistine Dimesilate 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 Betahistine Dimesilate suppliers with JDMF on PharmaCompass.
A Betahistine Dimesilate CEP of the European Pharmacopoeia monograph is often referred to as a Betahistine Dimesilate Certificate of Suitability (COS). The purpose of a Betahistine Dimesilate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betahistine Dimesilate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betahistine Dimesilate to their clients by showing that a Betahistine Dimesilate CEP has been issued for it. The manufacturer submits a Betahistine Dimesilate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betahistine Dimesilate CEP holder for the record. Additionally, the data presented in the Betahistine Dimesilate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betahistine Dimesilate DMF.
A Betahistine Dimesilate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betahistine Dimesilate 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 Betahistine Dimesilate suppliers with CEP (COS) on PharmaCompass.
Betahistine Dimesilate 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 Betahistine Dimesilate 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 Betahistine Dimesilate GMP manufacturer or Betahistine Dimesilate GMP API supplier for your needs.
A Betahistine Dimesilate CoA (Certificate of Analysis) is a formal document that attests to Betahistine Dimesilate's compliance with Betahistine Dimesilate specifications and serves as a tool for batch-level quality control.
Betahistine Dimesilate CoA mostly includes findings from lab analyses of a specific batch. For each Betahistine Dimesilate 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.
Betahistine Dimesilate may be tested according to a variety of international standards, such as European Pharmacopoeia (Betahistine Dimesilate EP), Betahistine Dimesilate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betahistine Dimesilate USP).
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