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