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