US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Donepezil 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 Donepezil manufacturer or Donepezil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Donepezil manufacturer or Donepezil supplier.
PharmaCompass also assists you with knowing the Donepezil API Price utilized in the formulation of products. Donepezil API Price is not always fixed or binding as the Donepezil Price is obtained through a variety of data sources. The Donepezil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Donepezil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Donepezil, including repackagers and relabelers. The FDA regulates Donepezil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Donepezil 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 Donepezil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Donepezil supplier is an individual or a company that provides Donepezil active pharmaceutical ingredient (API) or Donepezil finished formulations upon request. The Donepezil suppliers may include Donepezil API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Donepezil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Donepezil DMF (Drug Master File) is a document detailing the whole manufacturing process of Donepezil active pharmaceutical ingredient (API) in detail. Different forms of Donepezil DMFs exist exist since differing nations have different regulations, such as Donepezil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Donepezil DMF submitted to regulatory agencies in the US is known as a USDMF. Donepezil USDMF includes data on Donepezil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Donepezil 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 Donepezil Drug Master File in Japan (Donepezil JDMF) empowers Donepezil 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 Donepezil JDMF during the approval evaluation for pharmaceutical products. At the time of Donepezil JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Donepezil Drug Master File in Korea (Donepezil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Donepezil. The MFDS reviews the Donepezil KDMF as part of the drug registration process and uses the information provided in the Donepezil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Donepezil 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 Donepezil API can apply through the Korea Drug Master File (KDMF).
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A Donepezil CEP of the European Pharmacopoeia monograph is often referred to as a Donepezil Certificate of Suitability (COS). The purpose of a Donepezil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Donepezil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Donepezil to their clients by showing that a Donepezil CEP has been issued for it. The manufacturer submits a Donepezil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Donepezil CEP holder for the record. Additionally, the data presented in the Donepezil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Donepezil DMF.
A Donepezil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Donepezil CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Donepezil written confirmation (Donepezil WC) is an official document issued by a regulatory agency to a Donepezil manufacturer, verifying that the manufacturing facility of a Donepezil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Donepezil APIs or Donepezil finished pharmaceutical products to another nation, regulatory agencies frequently require a Donepezil WC (written confirmation) as part of the regulatory process.
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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 Donepezil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Donepezil 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 Donepezil 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 Donepezil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Donepezil NDC to their finished compounded human drug products, they may choose to do so.
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Donepezil 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 Donepezil 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 Donepezil GMP manufacturer or Donepezil GMP API supplier for your needs.
A Donepezil CoA (Certificate of Analysis) is a formal document that attests to Donepezil's compliance with Donepezil specifications and serves as a tool for batch-level quality control.
Donepezil CoA mostly includes findings from lab analyses of a specific batch. For each Donepezil 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.
Donepezil may be tested according to a variety of international standards, such as European Pharmacopoeia (Donepezil EP), Donepezil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Donepezil USP).