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DOSAGE - TABLET;ORAL - 40MG
USFDA APPLICATION NUMBER - 21856
DOSAGE - TABLET;ORAL - 80MG
USFDA APPLICATION NUMBER - 21856
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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 Febuxostat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Febuxostat manufacturer or Febuxostat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Febuxostat manufacturer or Febuxostat supplier.
A Feburic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Feburic, including repackagers and relabelers. The FDA regulates Feburic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Feburic 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 Feburic manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Feburic supplier is an individual or a company that provides Feburic active pharmaceutical ingredient (API) or Feburic finished formulations upon request. The Feburic suppliers may include Feburic API manufacturers, exporters, distributors and traders.
click here to find a list of Feburic suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Feburic DMF (Drug Master File) is a document detailing the whole manufacturing process of Feburic active pharmaceutical ingredient (API) in detail. Different forms of Feburic DMFs exist exist since differing nations have different regulations, such as Feburic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Feburic DMF submitted to regulatory agencies in the US is known as a USDMF. Feburic USDMF includes data on Feburic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Feburic USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Feburic 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 Feburic Drug Master File in Japan (Feburic JDMF) empowers Feburic 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 Feburic JDMF during the approval evaluation for pharmaceutical products. At the time of Feburic 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 Feburic 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 Feburic Drug Master File in Korea (Feburic KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Feburic. The MFDS reviews the Feburic KDMF as part of the drug registration process and uses the information provided in the Feburic KDMF to evaluate the safety and efficacy of the drug.
After submitting a Feburic 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 Feburic API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Feburic suppliers with KDMF on PharmaCompass.
A Feburic written confirmation (Feburic WC) is an official document issued by a regulatory agency to a Feburic manufacturer, verifying that the manufacturing facility of a Feburic active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Feburic APIs or Feburic finished pharmaceutical products to another nation, regulatory agencies frequently require a Feburic WC (written confirmation) as part of the regulatory process.
click here to find a list of Feburic 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 Feburic as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Feburic 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 Feburic 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 Feburic and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Feburic NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Feburic suppliers with NDC on PharmaCompass.
Feburic 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 Feburic GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Feburic GMP manufacturer or Feburic GMP API supplier for your needs.
A Feburic CoA (Certificate of Analysis) is a formal document that attests to Feburic's compliance with Feburic specifications and serves as a tool for batch-level quality control.
Feburic CoA mostly includes findings from lab analyses of a specific batch. For each Feburic 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.
Feburic may be tested according to a variety of international standards, such as European Pharmacopoeia (Feburic EP), Feburic JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Feburic USP).
