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ABOUT THIS PAGE
A Nalfurafine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalfurafine, including repackagers and relabelers. The FDA regulates Nalfurafine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalfurafine 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 Nalfurafine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nalfurafine supplier is an individual or a company that provides Nalfurafine active pharmaceutical ingredient (API) or Nalfurafine finished formulations upon request. The Nalfurafine suppliers may include Nalfurafine API manufacturers, exporters, distributors and traders.
click here to find a list of Nalfurafine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nalfurafine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nalfurafine active pharmaceutical ingredient (API) in detail. Different forms of Nalfurafine DMFs exist exist since differing nations have different regulations, such as Nalfurafine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nalfurafine DMF submitted to regulatory agencies in the US is known as a USDMF. Nalfurafine USDMF includes data on Nalfurafine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nalfurafine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nalfurafine 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 Nalfurafine Drug Master File in Japan (Nalfurafine JDMF) empowers Nalfurafine 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 Nalfurafine JDMF during the approval evaluation for pharmaceutical products. At the time of Nalfurafine 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 Nalfurafine 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 Nalfurafine Drug Master File in Korea (Nalfurafine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nalfurafine. The MFDS reviews the Nalfurafine KDMF as part of the drug registration process and uses the information provided in the Nalfurafine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nalfurafine 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 Nalfurafine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nalfurafine suppliers with KDMF on PharmaCompass.
Nalfurafine 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 Nalfurafine 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 Nalfurafine GMP manufacturer or Nalfurafine GMP API supplier for your needs.
A Nalfurafine CoA (Certificate of Analysis) is a formal document that attests to Nalfurafine's compliance with Nalfurafine specifications and serves as a tool for batch-level quality control.
Nalfurafine CoA mostly includes findings from lab analyses of a specific batch. For each Nalfurafine 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.
Nalfurafine may be tested according to a variety of international standards, such as European Pharmacopoeia (Nalfurafine EP), Nalfurafine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nalfurafine USP).
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