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