Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
ASMF, CA... 
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
CEP/COS
JDMF
KDMF
ASMF, CA...
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
ASMF, CA...
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USDMF
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-28
Pay. Date : 2013-03-20
DMF Number : 22974
Submission : 2009-07-22
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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Lubricants & Glidants
Thickeners and Stabilizers
Direct Compression
API Stability Enhancers
Fillers, Diluents & Binders
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
EDQM
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ABOUT THIS PAGE
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PharmaCompass offers a list of Rivastigmine 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 Rivastigmine manufacturer or Rivastigmine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rivastigmine manufacturer or Rivastigmine supplier.
PharmaCompass also assists you with knowing the Rivastigmine API Price utilized in the formulation of products. Rivastigmine API Price is not always fixed or binding as the Rivastigmine Price is obtained through a variety of data sources. The Rivastigmine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Exelon Patch manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exelon Patch, including repackagers and relabelers. The FDA regulates Exelon Patch manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exelon Patch 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 Exelon Patch manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Exelon Patch supplier is an individual or a company that provides Exelon Patch active pharmaceutical ingredient (API) or Exelon Patch finished formulations upon request. The Exelon Patch suppliers may include Exelon Patch API manufacturers, exporters, distributors and traders.
click here to find a list of Exelon Patch suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Exelon Patch DMF (Drug Master File) is a document detailing the whole manufacturing process of Exelon Patch active pharmaceutical ingredient (API) in detail. Different forms of Exelon Patch DMFs exist exist since differing nations have different regulations, such as Exelon Patch USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exelon Patch DMF submitted to regulatory agencies in the US is known as a USDMF. Exelon Patch USDMF includes data on Exelon Patch's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exelon Patch USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Exelon Patch 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 Exelon Patch Drug Master File in Japan (Exelon Patch JDMF) empowers Exelon Patch 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 Exelon Patch JDMF during the approval evaluation for pharmaceutical products. At the time of Exelon Patch 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 Exelon Patch 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 Exelon Patch Drug Master File in Korea (Exelon Patch KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Exelon Patch. The MFDS reviews the Exelon Patch KDMF as part of the drug registration process and uses the information provided in the Exelon Patch KDMF to evaluate the safety and efficacy of the drug.
After submitting a Exelon Patch 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 Exelon Patch API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Exelon Patch suppliers with KDMF on PharmaCompass.
A Exelon Patch CEP of the European Pharmacopoeia monograph is often referred to as a Exelon Patch Certificate of Suitability (COS). The purpose of a Exelon Patch CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Exelon Patch EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Exelon Patch to their clients by showing that a Exelon Patch CEP has been issued for it. The manufacturer submits a Exelon Patch CEP (COS) as part of the market authorization procedure, and it takes on the role of a Exelon Patch CEP holder for the record. Additionally, the data presented in the Exelon Patch CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Exelon Patch DMF.
A Exelon Patch CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Exelon Patch 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 Exelon Patch suppliers with CEP (COS) on PharmaCompass.
A Exelon Patch written confirmation (Exelon Patch WC) is an official document issued by a regulatory agency to a Exelon Patch manufacturer, verifying that the manufacturing facility of a Exelon Patch active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Exelon Patch APIs or Exelon Patch finished pharmaceutical products to another nation, regulatory agencies frequently require a Exelon Patch WC (written confirmation) as part of the regulatory process.
click here to find a list of Exelon Patch 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 Exelon Patch as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Exelon Patch 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 Exelon Patch 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 Exelon Patch and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Exelon Patch NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Exelon Patch suppliers with NDC on PharmaCompass.
Exelon Patch 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 Exelon Patch 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 Exelon Patch GMP manufacturer or Exelon Patch GMP API supplier for your needs.
A Exelon Patch CoA (Certificate of Analysis) is a formal document that attests to Exelon Patch's compliance with Exelon Patch specifications and serves as a tool for batch-level quality control.
Exelon Patch CoA mostly includes findings from lab analyses of a specific batch. For each Exelon Patch 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.
Exelon Patch may be tested according to a variety of international standards, such as European Pharmacopoeia (Exelon Patch EP), Exelon Patch JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Exelon Patch USP).
