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API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
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JDMF
KDMF
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.
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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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 Rivastigmine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rivastigmine, including repackagers and relabelers. The FDA regulates Rivastigmine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rivastigmine 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 Rivastigmine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rivastigmine supplier is an individual or a company that provides Rivastigmine active pharmaceutical ingredient (API) or Rivastigmine finished formulations upon request. The Rivastigmine suppliers may include Rivastigmine API manufacturers, exporters, distributors and traders.
click here to find a list of Rivastigmine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rivastigmine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rivastigmine active pharmaceutical ingredient (API) in detail. Different forms of Rivastigmine DMFs exist exist since differing nations have different regulations, such as Rivastigmine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rivastigmine DMF submitted to regulatory agencies in the US is known as a USDMF. Rivastigmine USDMF includes data on Rivastigmine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rivastigmine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rivastigmine 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 Rivastigmine Drug Master File in Japan (Rivastigmine JDMF) empowers Rivastigmine 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 Rivastigmine JDMF during the approval evaluation for pharmaceutical products. At the time of Rivastigmine 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 Rivastigmine 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 Rivastigmine Drug Master File in Korea (Rivastigmine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rivastigmine. The MFDS reviews the Rivastigmine KDMF as part of the drug registration process and uses the information provided in the Rivastigmine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rivastigmine 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 Rivastigmine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rivastigmine suppliers with KDMF on PharmaCompass.
A Rivastigmine CEP of the European Pharmacopoeia monograph is often referred to as a Rivastigmine Certificate of Suitability (COS). The purpose of a Rivastigmine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rivastigmine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rivastigmine to their clients by showing that a Rivastigmine CEP has been issued for it. The manufacturer submits a Rivastigmine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rivastigmine CEP holder for the record. Additionally, the data presented in the Rivastigmine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rivastigmine DMF.
A Rivastigmine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rivastigmine 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 Rivastigmine suppliers with CEP (COS) on PharmaCompass.
A Rivastigmine written confirmation (Rivastigmine WC) is an official document issued by a regulatory agency to a Rivastigmine manufacturer, verifying that the manufacturing facility of a Rivastigmine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rivastigmine APIs or Rivastigmine finished pharmaceutical products to another nation, regulatory agencies frequently require a Rivastigmine WC (written confirmation) as part of the regulatory process.
click here to find a list of Rivastigmine 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 Rivastigmine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rivastigmine 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 Rivastigmine 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 Rivastigmine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rivastigmine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rivastigmine suppliers with NDC on PharmaCompass.
Rivastigmine 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 Rivastigmine 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 Rivastigmine GMP manufacturer or Rivastigmine GMP API supplier for your needs.
A Rivastigmine CoA (Certificate of Analysis) is a formal document that attests to Rivastigmine's compliance with Rivastigmine specifications and serves as a tool for batch-level quality control.
Rivastigmine CoA mostly includes findings from lab analyses of a specific batch. For each Rivastigmine 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.
Rivastigmine may be tested according to a variety of international standards, such as European Pharmacopoeia (Rivastigmine EP), Rivastigmine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rivastigmine USP).
