Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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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.
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
Jai Radhe Sales is your partner for all your sourcing needs.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-31
Pay. Date : 2014-10-27
DMF Number : 17779
Submission : 2004-10-26
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-16
Pay. Date : 2020-10-23
DMF Number : 35172
Submission : 2020-10-05
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 21132
Submission : 2007-12-11
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-19
DMF Number : 23077
Submission : 2009-08-28
Status :
Type : II
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Neuland Laboratories- A dedicated 100% API provider.
Date of Issue : 2025-06-16
Valid Till : 2028-06-16
Written Confirmation Number : WC-0036
Address of the Firm : (Unit-l), Sy.No.291, 346P, 347, 348P, 473, 474, 490/2, Veerabhadraswamy Temple R...
Neuland Laboratories- A dedicated 100% API provider.
Donepezil Hydrochloride Monohydrate Ph. Eur
Date of Issue : 2025-06-16
Valid Till : 2028-06-16
Written Confirmation Number : WC-0036
Address of the Firm : (Unit-l), Sy.No.291, 346P, 347, 348P, 473, 474, 490/2, Veerabhadraswamy Temple R...
Neuland Laboratories- A dedicated 100% API provider.
Date of Issue : 2025-06-16
Valid Till : 2028-06-16
Written Confirmation Number : WC-0036
Address of the Firm : (Unit-l), Sy.No.291, 346P, 347, 348P, 473, 474, 490/2, Veerabhadraswamy Temple R...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 1126-09-6
End Use API : Donepezil
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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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, 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.
A Memorit manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memorit, including repackagers and relabelers. The FDA regulates Memorit manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memorit 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 Memorit manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Memorit supplier is an individual or a company that provides Memorit active pharmaceutical ingredient (API) or Memorit finished formulations upon request. The Memorit suppliers may include Memorit API manufacturers, exporters, distributors and traders.
click here to find a list of Memorit suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Memorit DMF (Drug Master File) is a document detailing the whole manufacturing process of Memorit active pharmaceutical ingredient (API) in detail. Different forms of Memorit DMFs exist exist since differing nations have different regulations, such as Memorit USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Memorit DMF submitted to regulatory agencies in the US is known as a USDMF. Memorit USDMF includes data on Memorit's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memorit USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Memorit 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 Memorit Drug Master File in Japan (Memorit JDMF) empowers Memorit 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 Memorit JDMF during the approval evaluation for pharmaceutical products. At the time of Memorit 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 Memorit 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 Memorit Drug Master File in Korea (Memorit KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Memorit. The MFDS reviews the Memorit KDMF as part of the drug registration process and uses the information provided in the Memorit KDMF to evaluate the safety and efficacy of the drug.
After submitting a Memorit 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 Memorit API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Memorit suppliers with KDMF on PharmaCompass.
A Memorit CEP of the European Pharmacopoeia monograph is often referred to as a Memorit Certificate of Suitability (COS). The purpose of a Memorit CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Memorit EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Memorit to their clients by showing that a Memorit CEP has been issued for it. The manufacturer submits a Memorit CEP (COS) as part of the market authorization procedure, and it takes on the role of a Memorit CEP holder for the record. Additionally, the data presented in the Memorit CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Memorit DMF.
A Memorit CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Memorit 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 Memorit suppliers with CEP (COS) on PharmaCompass.
A Memorit written confirmation (Memorit WC) is an official document issued by a regulatory agency to a Memorit manufacturer, verifying that the manufacturing facility of a Memorit active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Memorit APIs or Memorit finished pharmaceutical products to another nation, regulatory agencies frequently require a Memorit WC (written confirmation) as part of the regulatory process.
click here to find a list of Memorit 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 Memorit as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Memorit 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 Memorit 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 Memorit and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Memorit NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Memorit suppliers with NDC on PharmaCompass.
Memorit 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 Memorit GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Memorit GMP manufacturer or Memorit GMP API supplier for your needs.
A Memorit CoA (Certificate of Analysis) is a formal document that attests to Memorit's compliance with Memorit specifications and serves as a tool for batch-level quality control.
Memorit CoA mostly includes findings from lab analyses of a specific batch. For each Memorit 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.
Memorit may be tested according to a variety of international standards, such as European Pharmacopoeia (Memorit EP), Memorit JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Memorit USP).
