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PharmaCompass offers a list of Doxapram Hydrochloride 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 Doxapram Hydrochloride manufacturer or Doxapram Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doxapram Hydrochloride manufacturer or Doxapram Hydrochloride supplier.
PharmaCompass also assists you with knowing the Doxapram Hydrochloride API Price utilized in the formulation of products. Doxapram Hydrochloride API Price is not always fixed or binding as the Doxapram Hydrochloride Price is obtained through a variety of data sources. The Doxapram Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Docatone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Docatone, including repackagers and relabelers. The FDA regulates Docatone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Docatone 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 Docatone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Docatone supplier is an individual or a company that provides Docatone active pharmaceutical ingredient (API) or Docatone finished formulations upon request. The Docatone suppliers may include Docatone API manufacturers, exporters, distributors and traders.
click here to find a list of Docatone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Docatone DMF (Drug Master File) is a document detailing the whole manufacturing process of Docatone active pharmaceutical ingredient (API) in detail. Different forms of Docatone DMFs exist exist since differing nations have different regulations, such as Docatone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Docatone DMF submitted to regulatory agencies in the US is known as a USDMF. Docatone USDMF includes data on Docatone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Docatone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Docatone suppliers with USDMF on PharmaCompass.
A Docatone CEP of the European Pharmacopoeia monograph is often referred to as a Docatone Certificate of Suitability (COS). The purpose of a Docatone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Docatone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Docatone to their clients by showing that a Docatone CEP has been issued for it. The manufacturer submits a Docatone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Docatone CEP holder for the record. Additionally, the data presented in the Docatone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Docatone DMF.
A Docatone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Docatone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Docatone suppliers with CEP (COS) on PharmaCompass.
A Docatone written confirmation (Docatone WC) is an official document issued by a regulatory agency to a Docatone manufacturer, verifying that the manufacturing facility of a Docatone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Docatone APIs or Docatone finished pharmaceutical products to another nation, regulatory agencies frequently require a Docatone WC (written confirmation) as part of the regulatory process.
click here to find a list of Docatone 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 Docatone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Docatone 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 Docatone 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 Docatone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Docatone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Docatone suppliers with NDC on PharmaCompass.
Docatone 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 Docatone 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 Docatone GMP manufacturer or Docatone GMP API supplier for your needs.
A Docatone CoA (Certificate of Analysis) is a formal document that attests to Docatone's compliance with Docatone specifications and serves as a tool for batch-level quality control.
Docatone CoA mostly includes findings from lab analyses of a specific batch. For each Docatone 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.
Docatone may be tested according to a variety of international standards, such as European Pharmacopoeia (Docatone EP), Docatone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Docatone USP).
