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PharmaCompass offers a list of Benzethonium Chloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Benzethonium Chloride manufacturer or Benzethonium Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzethonium Chloride manufacturer or Benzethonium Chloride supplier.
PharmaCompass also assists you with knowing the Benzethonium Chloride API Price utilized in the formulation of products. Benzethonium Chloride API Price is not always fixed or binding as the Benzethonium Chloride Price is obtained through a variety of data sources. The Benzethonium Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benzethonium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzethonium, including repackagers and relabelers. The FDA regulates Benzethonium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzethonium 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 Benzethonium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzethonium supplier is an individual or a company that provides Benzethonium active pharmaceutical ingredient (API) or Benzethonium finished formulations upon request. The Benzethonium suppliers may include Benzethonium API manufacturers, exporters, distributors and traders.
click here to find a list of Benzethonium 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 Benzethonium Drug Master File in Japan (Benzethonium JDMF) empowers Benzethonium 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 Benzethonium JDMF during the approval evaluation for pharmaceutical products. At the time of Benzethonium 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 Benzethonium suppliers with JDMF on PharmaCompass.
A Benzethonium written confirmation (Benzethonium WC) is an official document issued by a regulatory agency to a Benzethonium manufacturer, verifying that the manufacturing facility of a Benzethonium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benzethonium APIs or Benzethonium finished pharmaceutical products to another nation, regulatory agencies frequently require a Benzethonium WC (written confirmation) as part of the regulatory process.
click here to find a list of Benzethonium 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 Benzethonium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Benzethonium 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 Benzethonium 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 Benzethonium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Benzethonium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Benzethonium suppliers with NDC on PharmaCompass.
Benzethonium 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 Benzethonium 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 Benzethonium GMP manufacturer or Benzethonium GMP API supplier for your needs.
A Benzethonium CoA (Certificate of Analysis) is a formal document that attests to Benzethonium's compliance with Benzethonium specifications and serves as a tool for batch-level quality control.
Benzethonium CoA mostly includes findings from lab analyses of a specific batch. For each Benzethonium 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.
Benzethonium may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzethonium EP), Benzethonium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzethonium USP).