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