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API SUPPLIERS
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USDMF
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ABOUT THIS PAGE
A Tegafur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tegafur, including repackagers and relabelers. The FDA regulates Tegafur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tegafur 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 Tegafur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tegafur supplier is an individual or a company that provides Tegafur active pharmaceutical ingredient (API) or Tegafur finished formulations upon request. The Tegafur suppliers may include Tegafur API manufacturers, exporters, distributors and traders.
click here to find a list of Tegafur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tegafur DMF (Drug Master File) is a document detailing the whole manufacturing process of Tegafur active pharmaceutical ingredient (API) in detail. Different forms of Tegafur DMFs exist exist since differing nations have different regulations, such as Tegafur USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tegafur DMF submitted to regulatory agencies in the US is known as a USDMF. Tegafur USDMF includes data on Tegafur's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tegafur USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tegafur 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 Tegafur Drug Master File in Japan (Tegafur JDMF) empowers Tegafur 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 Tegafur JDMF during the approval evaluation for pharmaceutical products. At the time of Tegafur 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 Tegafur 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 Tegafur Drug Master File in Korea (Tegafur KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tegafur. The MFDS reviews the Tegafur KDMF as part of the drug registration process and uses the information provided in the Tegafur KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tegafur 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 Tegafur API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tegafur suppliers with KDMF on PharmaCompass.
A Tegafur written confirmation (Tegafur WC) is an official document issued by a regulatory agency to a Tegafur manufacturer, verifying that the manufacturing facility of a Tegafur active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tegafur APIs or Tegafur finished pharmaceutical products to another nation, regulatory agencies frequently require a Tegafur WC (written confirmation) as part of the regulatory process.
click here to find a list of Tegafur suppliers with Written Confirmation (WC) on PharmaCompass.
Tegafur 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 Tegafur 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 Tegafur GMP manufacturer or Tegafur GMP API supplier for your needs.
A Tegafur CoA (Certificate of Analysis) is a formal document that attests to Tegafur's compliance with Tegafur specifications and serves as a tool for batch-level quality control.
Tegafur CoA mostly includes findings from lab analyses of a specific batch. For each Tegafur 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.
Tegafur may be tested according to a variety of international standards, such as European Pharmacopoeia (Tegafur EP), Tegafur JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tegafur USP).
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