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