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ABOUT THIS PAGE
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PharmaCompass offers a list of Sofalcone 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 Sofalcone manufacturer or Sofalcone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sofalcone manufacturer or Sofalcone supplier.
PharmaCompass also assists you with knowing the Sofalcone API Price utilized in the formulation of products. Sofalcone API Price is not always fixed or binding as the Sofalcone Price is obtained through a variety of data sources. The Sofalcone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Solon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solon, including repackagers and relabelers. The FDA regulates Solon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solon 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 Solon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Solon supplier is an individual or a company that provides Solon active pharmaceutical ingredient (API) or Solon finished formulations upon request. The Solon suppliers may include Solon API manufacturers, exporters, distributors and traders.
click here to find a list of Solon 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 Solon Drug Master File in Japan (Solon JDMF) empowers Solon 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 Solon JDMF during the approval evaluation for pharmaceutical products. At the time of Solon 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 Solon suppliers with JDMF on PharmaCompass.
Solon 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 Solon 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 Solon GMP manufacturer or Solon GMP API supplier for your needs.
A Solon CoA (Certificate of Analysis) is a formal document that attests to Solon's compliance with Solon specifications and serves as a tool for batch-level quality control.
Solon CoA mostly includes findings from lab analyses of a specific batch. For each Solon 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.
Solon may be tested according to a variety of international standards, such as European Pharmacopoeia (Solon EP), Solon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Solon USP).
