API Suppliers
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PharmaCompass offers a list of Tolcapone 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 Tolcapone manufacturer or Tolcapone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tolcapone manufacturer or Tolcapone supplier.
PharmaCompass also assists you with knowing the Tolcapone API Price utilized in the formulation of products. Tolcapone API Price is not always fixed or binding as the Tolcapone Price is obtained through a variety of data sources. The Tolcapone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tolcapone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolcapone, including repackagers and relabelers. The FDA regulates Tolcapone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolcapone 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 Tolcapone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolcapone supplier is an individual or a company that provides Tolcapone active pharmaceutical ingredient (API) or Tolcapone finished formulations upon request. The Tolcapone suppliers may include Tolcapone API manufacturers, exporters, distributors and traders.
click here to find a list of Tolcapone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tolcapone DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolcapone active pharmaceutical ingredient (API) in detail. Different forms of Tolcapone DMFs exist exist since differing nations have different regulations, such as Tolcapone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolcapone DMF submitted to regulatory agencies in the US is known as a USDMF. Tolcapone USDMF includes data on Tolcapone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolcapone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolcapone suppliers with USDMF on PharmaCompass.
A Tolcapone written confirmation (Tolcapone WC) is an official document issued by a regulatory agency to a Tolcapone manufacturer, verifying that the manufacturing facility of a Tolcapone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tolcapone APIs or Tolcapone finished pharmaceutical products to another nation, regulatory agencies frequently require a Tolcapone WC (written confirmation) as part of the regulatory process.
click here to find a list of Tolcapone 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 Tolcapone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tolcapone 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 Tolcapone 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 Tolcapone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tolcapone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tolcapone suppliers with NDC on PharmaCompass.
Tolcapone 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 Tolcapone 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 Tolcapone GMP manufacturer or Tolcapone GMP API supplier for your needs.
A Tolcapone CoA (Certificate of Analysis) is a formal document that attests to Tolcapone's compliance with Tolcapone specifications and serves as a tool for batch-level quality control.
Tolcapone CoA mostly includes findings from lab analyses of a specific batch. For each Tolcapone 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.
Tolcapone may be tested according to a variety of international standards, such as European Pharmacopoeia (Tolcapone EP), Tolcapone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tolcapone USP).