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ABOUT THIS PAGE
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PharmaCompass offers a list of Danazol 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 Danazol manufacturer or Danazol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Danazol manufacturer or Danazol supplier.
PharmaCompass also assists you with knowing the Danazol API Price utilized in the formulation of products. Danazol API Price is not always fixed or binding as the Danazol Price is obtained through a variety of data sources. The Danazol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Danazol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Danazol, including repackagers and relabelers. The FDA regulates Danazol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Danazol 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 Danazol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Danazol supplier is an individual or a company that provides Danazol active pharmaceutical ingredient (API) or Danazol finished formulations upon request. The Danazol suppliers may include Danazol API manufacturers, exporters, distributors and traders.
click here to find a list of Danazol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Danazol DMF (Drug Master File) is a document detailing the whole manufacturing process of Danazol active pharmaceutical ingredient (API) in detail. Different forms of Danazol DMFs exist exist since differing nations have different regulations, such as Danazol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Danazol DMF submitted to regulatory agencies in the US is known as a USDMF. Danazol USDMF includes data on Danazol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Danazol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Danazol suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Danazol Drug Master File in Korea (Danazol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Danazol. The MFDS reviews the Danazol KDMF as part of the drug registration process and uses the information provided in the Danazol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Danazol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Danazol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Danazol suppliers with KDMF on PharmaCompass.
A Danazol written confirmation (Danazol WC) is an official document issued by a regulatory agency to a Danazol manufacturer, verifying that the manufacturing facility of a Danazol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Danazol APIs or Danazol finished pharmaceutical products to another nation, regulatory agencies frequently require a Danazol WC (written confirmation) as part of the regulatory process.
click here to find a list of Danazol 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 Danazol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Danazol 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 Danazol 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 Danazol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Danazol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Danazol suppliers with NDC on PharmaCompass.
Danazol 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 Danazol 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 Danazol GMP manufacturer or Danazol GMP API supplier for your needs.
A Danazol CoA (Certificate of Analysis) is a formal document that attests to Danazol's compliance with Danazol specifications and serves as a tool for batch-level quality control.
Danazol CoA mostly includes findings from lab analyses of a specific batch. For each Danazol 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.
Danazol may be tested according to a variety of international standards, such as European Pharmacopoeia (Danazol EP), Danazol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Danazol USP).
