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