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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 Sofalcone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sofalcone, including repackagers and relabelers. The FDA regulates Sofalcone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sofalcone 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 Sofalcone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sofalcone supplier is an individual or a company that provides Sofalcone active pharmaceutical ingredient (API) or Sofalcone finished formulations upon request. The Sofalcone suppliers may include Sofalcone API manufacturers, exporters, distributors and traders.
click here to find a list of Sofalcone 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 Sofalcone Drug Master File in Japan (Sofalcone JDMF) empowers Sofalcone 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 Sofalcone JDMF during the approval evaluation for pharmaceutical products. At the time of Sofalcone 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 Sofalcone suppliers with JDMF on PharmaCompass.
Sofalcone 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 Sofalcone 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 Sofalcone GMP manufacturer or Sofalcone GMP API supplier for your needs.
A Sofalcone CoA (Certificate of Analysis) is a formal document that attests to Sofalcone's compliance with Sofalcone specifications and serves as a tool for batch-level quality control.
Sofalcone CoA mostly includes findings from lab analyses of a specific batch. For each Sofalcone 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.
Sofalcone may be tested according to a variety of international standards, such as European Pharmacopoeia (Sofalcone EP), Sofalcone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sofalcone USP).
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