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Data Compilation #PharmaFlow
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ABOUT THIS PAGE
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PharmaCompass offers a list of Fudosteine 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 Fudosteine manufacturer or Fudosteine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fudosteine manufacturer or Fudosteine supplier.
PharmaCompass also assists you with knowing the Fudosteine API Price utilized in the formulation of products. Fudosteine API Price is not always fixed or binding as the Fudosteine Price is obtained through a variety of data sources. The Fudosteine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cleanal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cleanal, including repackagers and relabelers. The FDA regulates Cleanal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cleanal API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Cleanal supplier is an individual or a company that provides Cleanal active pharmaceutical ingredient (API) or Cleanal finished formulations upon request. The Cleanal suppliers may include Cleanal API manufacturers, exporters, distributors and traders.
click here to find a list of Cleanal 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 Cleanal Drug Master File in Japan (Cleanal JDMF) empowers Cleanal 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 Cleanal JDMF during the approval evaluation for pharmaceutical products. At the time of Cleanal 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 Cleanal 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 Cleanal Drug Master File in Korea (Cleanal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cleanal. The MFDS reviews the Cleanal KDMF as part of the drug registration process and uses the information provided in the Cleanal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cleanal 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 Cleanal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cleanal suppliers with KDMF on PharmaCompass.
Cleanal 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 Cleanal 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 Cleanal GMP manufacturer or Cleanal GMP API supplier for your needs.
A Cleanal CoA (Certificate of Analysis) is a formal document that attests to Cleanal's compliance with Cleanal specifications and serves as a tool for batch-level quality control.
Cleanal CoA mostly includes findings from lab analyses of a specific batch. For each Cleanal 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.
Cleanal may be tested according to a variety of international standards, such as European Pharmacopoeia (Cleanal EP), Cleanal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cleanal USP).
