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ABOUT THIS PAGE
A Benzarone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzarone, including repackagers and relabelers. The FDA regulates Benzarone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzarone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzarone supplier is an individual or a company that provides Benzarone active pharmaceutical ingredient (API) or Benzarone finished formulations upon request. The Benzarone suppliers may include Benzarone API manufacturers, exporters, distributors and traders.
click here to find a list of Benzarone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Benzarone Drug Master File in Japan (Benzarone JDMF) empowers Benzarone 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 Benzarone JDMF during the approval evaluation for pharmaceutical products. At the time of Benzarone 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 Benzarone suppliers with JDMF on PharmaCompass.
A Benzarone written confirmation (Benzarone WC) is an official document issued by a regulatory agency to a Benzarone manufacturer, verifying that the manufacturing facility of a Benzarone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benzarone APIs or Benzarone finished pharmaceutical products to another nation, regulatory agencies frequently require a Benzarone WC (written confirmation) as part of the regulatory process.
click here to find a list of Benzarone suppliers with Written Confirmation (WC) on PharmaCompass.
Benzarone 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 Benzarone 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 Benzarone GMP manufacturer or Benzarone GMP API supplier for your needs.
A Benzarone CoA (Certificate of Analysis) is a formal document that attests to Benzarone's compliance with Benzarone specifications and serves as a tool for batch-level quality control.
Benzarone CoA mostly includes findings from lab analyses of a specific batch. For each Benzarone 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.
Benzarone may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzarone EP), Benzarone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzarone USP).
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