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API SUPPLIERS
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Jai Radhe Sales is your partner for all your sourcing needs.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
ASMF
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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USDMF
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Neuland Laboratories- A dedicated 100% API provider.
Donepezil Hydrochloride Monohydrate, Monohydrate
Certificate Number : CEP 2019-311 - Rev 01
Status : Valid
Issue Date : 2024-01-31
Type : Chemical
Substance Number : 3067
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 20690
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 20690
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG
USFDA APPLICATION NUMBER - 21720
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 5MG
USFDA APPLICATION NUMBER - 21720
DOSAGE - TABLET;ORAL - 23MG
USFDA APPLICATION NUMBER - 22568
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ABOUT THIS PAGE
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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 hydrochloride, Aricept manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Donepezil hydrochloride, Aricept, including repackagers and relabelers. The FDA regulates Donepezil hydrochloride, Aricept manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Donepezil hydrochloride, Aricept 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, Aricept manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Donepezil hydrochloride, Aricept supplier is an individual or a company that provides Donepezil hydrochloride, Aricept active pharmaceutical ingredient (API) or Donepezil hydrochloride, Aricept finished formulations upon request. The Donepezil hydrochloride, Aricept suppliers may include Donepezil hydrochloride, Aricept API manufacturers, exporters, distributors and traders.
click here to find a list of Donepezil hydrochloride, Aricept suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Donepezil hydrochloride, Aricept DMF (Drug Master File) is a document detailing the whole manufacturing process of Donepezil hydrochloride, Aricept active pharmaceutical ingredient (API) in detail. Different forms of Donepezil hydrochloride, Aricept DMFs exist exist since differing nations have different regulations, such as Donepezil hydrochloride, Aricept USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Donepezil hydrochloride, Aricept DMF submitted to regulatory agencies in the US is known as a USDMF. Donepezil hydrochloride, Aricept USDMF includes data on Donepezil hydrochloride, Aricept's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Donepezil hydrochloride, Aricept USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Donepezil hydrochloride, Aricept 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 Donepezil hydrochloride, Aricept Drug Master File in Japan (Donepezil hydrochloride, Aricept JDMF) empowers Donepezil hydrochloride, Aricept 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, Aricept JDMF during the approval evaluation for pharmaceutical products. At the time of Donepezil hydrochloride, Aricept 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 Donepezil hydrochloride, Aricept 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 Donepezil hydrochloride, Aricept Drug Master File in Korea (Donepezil hydrochloride, Aricept KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Donepezil hydrochloride, Aricept. The MFDS reviews the Donepezil hydrochloride, Aricept KDMF as part of the drug registration process and uses the information provided in the Donepezil hydrochloride, Aricept KDMF to evaluate the safety and efficacy of the drug.
After submitting a Donepezil hydrochloride, Aricept 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, Aricept API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Donepezil hydrochloride, Aricept suppliers with KDMF on PharmaCompass.
A Donepezil hydrochloride, Aricept CEP of the European Pharmacopoeia monograph is often referred to as a Donepezil hydrochloride, Aricept Certificate of Suitability (COS). The purpose of a Donepezil hydrochloride, Aricept CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Donepezil hydrochloride, Aricept EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Donepezil hydrochloride, Aricept to their clients by showing that a Donepezil hydrochloride, Aricept CEP has been issued for it. The manufacturer submits a Donepezil hydrochloride, Aricept CEP (COS) as part of the market authorization procedure, and it takes on the role of a Donepezil hydrochloride, Aricept CEP holder for the record. Additionally, the data presented in the Donepezil hydrochloride, Aricept CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Donepezil hydrochloride, Aricept DMF.
A Donepezil hydrochloride, Aricept CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Donepezil hydrochloride, Aricept CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Donepezil hydrochloride, Aricept suppliers with CEP (COS) on PharmaCompass.
A Donepezil hydrochloride, Aricept written confirmation (Donepezil hydrochloride, Aricept WC) is an official document issued by a regulatory agency to a Donepezil hydrochloride, Aricept manufacturer, verifying that the manufacturing facility of a Donepezil hydrochloride, Aricept active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Donepezil hydrochloride, Aricept APIs or Donepezil hydrochloride, Aricept finished pharmaceutical products to another nation, regulatory agencies frequently require a Donepezil hydrochloride, Aricept WC (written confirmation) as part of the regulatory process.
click here to find a list of Donepezil hydrochloride, Aricept 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, Aricept as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Donepezil hydrochloride, Aricept 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, Aricept 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, Aricept and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Donepezil hydrochloride, Aricept NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Donepezil hydrochloride, Aricept suppliers with NDC on PharmaCompass.
Donepezil hydrochloride, Aricept 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, Aricept 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, Aricept GMP manufacturer or Donepezil hydrochloride, Aricept GMP API supplier for your needs.
A Donepezil hydrochloride, Aricept CoA (Certificate of Analysis) is a formal document that attests to Donepezil hydrochloride, Aricept's compliance with Donepezil hydrochloride, Aricept specifications and serves as a tool for batch-level quality control.
Donepezil hydrochloride, Aricept CoA mostly includes findings from lab analyses of a specific batch. For each Donepezil hydrochloride, Aricept 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, Aricept may be tested according to a variety of international standards, such as European Pharmacopoeia (Donepezil hydrochloride, Aricept EP), Donepezil hydrochloride, Aricept JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Donepezil hydrochloride, Aricept USP).
