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