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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nafamostat, including repackagers and relabelers. The FDA regulates Nafamostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nafamostat 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nafamostat supplier is an individual or a company that provides Nafamostat active pharmaceutical ingredient (API) or Nafamostat finished formulations upon request. The Nafamostat suppliers may include Nafamostat API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Nafamostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nafamostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Nafamostat active pharmaceutical ingredient (API) in detail. Different forms of Nafamostat DMFs exist exist since differing nations have different regulations, such as Nafamostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nafamostat DMF submitted to regulatory agencies in the US is known as a USDMF. Nafamostat USDMF includes data on Nafamostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nafamostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Drug Master File in Japan (Nafamostat JDMF) empowers Nafamostat 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Nafamostat 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 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 Drug Master File in Korea (Nafamostat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nafamostat. The MFDS reviews the Nafamostat KDMF as part of the drug registration process and uses the information provided in the Nafamostat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nafamostat 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 API can apply through the Korea Drug Master File (KDMF).
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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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nafamostat 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nafamostat NDC to their finished compounded human drug products, they may choose to do so.
CLICK HERE to find a list of Nafamostat suppliers with NDC on PharmaCompass.
Nafamostat 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 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 GMP manufacturer or Nafamostat GMP API supplier for your needs.
A Nafamostat CoA (Certificate of Analysis) is a formal document that attests to Nafamostat's compliance with Nafamostat specifications and serves as a tool for batch-level quality control.
Nafamostat CoA mostly includes findings from lab analyses of a specific batch. For each Nafamostat 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Nafamostat EP), Nafamostat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nafamostat USP).