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API SUPPLIERS
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USDMF
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PharmaCompass offers a list of Nalfurafine 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 Nalfurafine manufacturer or Nalfurafine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nalfurafine manufacturer or Nalfurafine supplier.
PharmaCompass also assists you with knowing the Nalfurafine API Price utilized in the formulation of products. Nalfurafine API Price is not always fixed or binding as the Nalfurafine Price is obtained through a variety of data sources. The Nalfurafine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A nalfurafine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of nalfurafine hydrochloride, including repackagers and relabelers. The FDA regulates nalfurafine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. nalfurafine hydrochloride 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 hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A nalfurafine hydrochloride supplier is an individual or a company that provides nalfurafine hydrochloride active pharmaceutical ingredient (API) or nalfurafine hydrochloride finished formulations upon request. The nalfurafine hydrochloride suppliers may include nalfurafine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of nalfurafine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A nalfurafine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of nalfurafine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of nalfurafine hydrochloride DMFs exist exist since differing nations have different regulations, such as nalfurafine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A nalfurafine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. nalfurafine hydrochloride USDMF includes data on nalfurafine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The nalfurafine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of nalfurafine hydrochloride 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 hydrochloride Drug Master File in Japan (nalfurafine hydrochloride JDMF) empowers nalfurafine hydrochloride 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 hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of nalfurafine hydrochloride 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 hydrochloride 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 hydrochloride Drug Master File in Korea (nalfurafine hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of nalfurafine hydrochloride. The MFDS reviews the nalfurafine hydrochloride KDMF as part of the drug registration process and uses the information provided in the nalfurafine hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a nalfurafine hydrochloride 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 hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of nalfurafine hydrochloride suppliers with KDMF on PharmaCompass.
nalfurafine hydrochloride 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 hydrochloride 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 hydrochloride GMP manufacturer or nalfurafine hydrochloride GMP API supplier for your needs.
A nalfurafine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to nalfurafine hydrochloride's compliance with nalfurafine hydrochloride specifications and serves as a tool for batch-level quality control.
nalfurafine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each nalfurafine hydrochloride 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 hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (nalfurafine hydrochloride EP), nalfurafine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (nalfurafine hydrochloride USP).
