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