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PharmaCompass offers a list of Nafamostat 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 Nafamostat manufacturer or Nafamostat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nafamostat manufacturer or Nafamostat supplier.
PharmaCompass also assists you with knowing the Nafamostat API Price utilized in the formulation of products. Nafamostat API Price is not always fixed or binding as the Nafamostat Price is obtained through a variety of data sources. The Nafamostat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nafamostat Mesilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nafamostat Mesilate, including repackagers and relabelers. The FDA regulates Nafamostat Mesilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nafamostat Mesilate 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 Nafamostat Mesilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nafamostat Mesilate supplier is an individual or a company that provides Nafamostat Mesilate active pharmaceutical ingredient (API) or Nafamostat Mesilate finished formulations upon request. The Nafamostat Mesilate suppliers may include Nafamostat Mesilate API manufacturers, exporters, distributors and traders.
click here to find a list of Nafamostat Mesilate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nafamostat Mesilate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nafamostat Mesilate active pharmaceutical ingredient (API) in detail. Different forms of Nafamostat Mesilate DMFs exist exist since differing nations have different regulations, such as Nafamostat Mesilate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nafamostat Mesilate DMF submitted to regulatory agencies in the US is known as a USDMF. Nafamostat Mesilate USDMF includes data on Nafamostat Mesilate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nafamostat Mesilate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nafamostat Mesilate suppliers with USDMF 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 Nafamostat Mesilate Drug Master File in Japan (Nafamostat Mesilate JDMF) empowers Nafamostat Mesilate 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 Nafamostat Mesilate JDMF during the approval evaluation for pharmaceutical products. At the time of Nafamostat Mesilate 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 Nafamostat Mesilate 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 Nafamostat Mesilate Drug Master File in Korea (Nafamostat Mesilate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nafamostat Mesilate. The MFDS reviews the Nafamostat Mesilate KDMF as part of the drug registration process and uses the information provided in the Nafamostat Mesilate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nafamostat Mesilate 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 Nafamostat Mesilate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nafamostat Mesilate suppliers with KDMF on PharmaCompass.
A Nafamostat Mesilate written confirmation (Nafamostat Mesilate WC) is an official document issued by a regulatory agency to a Nafamostat Mesilate manufacturer, verifying that the manufacturing facility of a Nafamostat Mesilate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nafamostat Mesilate APIs or Nafamostat Mesilate finished pharmaceutical products to another nation, regulatory agencies frequently require a Nafamostat Mesilate WC (written confirmation) as part of the regulatory process.
click here to find a list of Nafamostat Mesilate suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nafamostat Mesilate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nafamostat Mesilate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Nafamostat Mesilate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Nafamostat Mesilate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nafamostat Mesilate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nafamostat Mesilate suppliers with NDC on PharmaCompass.
Nafamostat Mesilate 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 Nafamostat Mesilate 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 Nafamostat Mesilate GMP manufacturer or Nafamostat Mesilate GMP API supplier for your needs.
A Nafamostat Mesilate CoA (Certificate of Analysis) is a formal document that attests to Nafamostat Mesilate's compliance with Nafamostat Mesilate specifications and serves as a tool for batch-level quality control.
Nafamostat Mesilate CoA mostly includes findings from lab analyses of a specific batch. For each Nafamostat Mesilate 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.
Nafamostat Mesilate may be tested according to a variety of international standards, such as European Pharmacopoeia (Nafamostat Mesilate EP), Nafamostat Mesilate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nafamostat Mesilate USP).
