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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Cystine 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 Cystine manufacturer or Cystine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cystine manufacturer or Cystine supplier.
PharmaCompass also assists you with knowing the Cystine API Price utilized in the formulation of products. Cystine API Price is not always fixed or binding as the Cystine Price is obtained through a variety of data sources. The Cystine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Copper Cystinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copper Cystinate, including repackagers and relabelers. The FDA regulates Copper Cystinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copper Cystinate 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 Copper Cystinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Copper Cystinate supplier is an individual or a company that provides Copper Cystinate active pharmaceutical ingredient (API) or Copper Cystinate finished formulations upon request. The Copper Cystinate suppliers may include Copper Cystinate API manufacturers, exporters, distributors and traders.
click here to find a list of Copper Cystinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Copper Cystinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Copper Cystinate active pharmaceutical ingredient (API) in detail. Different forms of Copper Cystinate DMFs exist exist since differing nations have different regulations, such as Copper Cystinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Copper Cystinate DMF submitted to regulatory agencies in the US is known as a USDMF. Copper Cystinate USDMF includes data on Copper Cystinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copper Cystinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Copper Cystinate 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 Copper Cystinate Drug Master File in Japan (Copper Cystinate JDMF) empowers Copper Cystinate 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 Copper Cystinate JDMF during the approval evaluation for pharmaceutical products. At the time of Copper Cystinate 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 Copper Cystinate suppliers with JDMF on PharmaCompass.
A Copper Cystinate CEP of the European Pharmacopoeia monograph is often referred to as a Copper Cystinate Certificate of Suitability (COS). The purpose of a Copper Cystinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Copper Cystinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Copper Cystinate to their clients by showing that a Copper Cystinate CEP has been issued for it. The manufacturer submits a Copper Cystinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Copper Cystinate CEP holder for the record. Additionally, the data presented in the Copper Cystinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Copper Cystinate DMF.
A Copper Cystinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Copper Cystinate 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 Copper Cystinate suppliers with CEP (COS) on PharmaCompass.
A Copper Cystinate written confirmation (Copper Cystinate WC) is an official document issued by a regulatory agency to a Copper Cystinate manufacturer, verifying that the manufacturing facility of a Copper Cystinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Copper Cystinate APIs or Copper Cystinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Copper Cystinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Copper Cystinate 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 Copper Cystinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Copper Cystinate 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 Copper Cystinate 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 Copper Cystinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Copper Cystinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Copper Cystinate suppliers with NDC on PharmaCompass.
Copper Cystinate 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 Copper Cystinate 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 Copper Cystinate GMP manufacturer or Copper Cystinate GMP API supplier for your needs.
A Copper Cystinate CoA (Certificate of Analysis) is a formal document that attests to Copper Cystinate's compliance with Copper Cystinate specifications and serves as a tool for batch-level quality control.
Copper Cystinate CoA mostly includes findings from lab analyses of a specific batch. For each Copper Cystinate 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.
Copper Cystinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Copper Cystinate EP), Copper Cystinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Copper Cystinate USP).
