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LEBSA- Your strategic API source for niche molecules.
ASMF 
Axplora is your partner of choice for complex APIs.
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LEBSA- Your strategic API source for niche molecules.
About the Company : Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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PharmaCompass offers a list of Betahistine Dimesilate 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 Betahistine Dimesilate manufacturer or Betahistine Dimesilate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betahistine Dimesilate manufacturer or Betahistine Dimesilate supplier.
PharmaCompass also assists you with knowing the Betahistine Dimesilate API Price utilized in the formulation of products. Betahistine Dimesilate API Price is not always fixed or binding as the Betahistine Dimesilate Price is obtained through a variety of data sources. The Betahistine Dimesilate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Merislon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Merislon, including repackagers and relabelers. The FDA regulates Merislon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Merislon 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 Merislon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Merislon supplier is an individual or a company that provides Merislon active pharmaceutical ingredient (API) or Merislon finished formulations upon request. The Merislon suppliers may include Merislon API manufacturers, exporters, distributors and traders.
click here to find a list of Merislon 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 Merislon Drug Master File in Japan (Merislon JDMF) empowers Merislon 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 Merislon JDMF during the approval evaluation for pharmaceutical products. At the time of Merislon 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 Merislon suppliers with JDMF on PharmaCompass.
A Merislon CEP of the European Pharmacopoeia monograph is often referred to as a Merislon Certificate of Suitability (COS). The purpose of a Merislon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Merislon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Merislon to their clients by showing that a Merislon CEP has been issued for it. The manufacturer submits a Merislon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Merislon CEP holder for the record. Additionally, the data presented in the Merislon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Merislon DMF.
A Merislon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Merislon 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 Merislon suppliers with CEP (COS) on PharmaCompass.
Merislon 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 Merislon 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 Merislon GMP manufacturer or Merislon GMP API supplier for your needs.
A Merislon CoA (Certificate of Analysis) is a formal document that attests to Merislon's compliance with Merislon specifications and serves as a tool for batch-level quality control.
Merislon CoA mostly includes findings from lab analyses of a specific batch. For each Merislon 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.
Merislon may be tested according to a variety of international standards, such as European Pharmacopoeia (Merislon EP), Merislon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Merislon USP).
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