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