![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-desktop-headergif-72716.gif)
![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-mob-headergif-95876.gif)
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
JDMFs Filed
0
EU WC
Listed Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
94
PharmaCompass offers a list of Dithranol 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 Dithranol manufacturer or Dithranol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dithranol manufacturer or Dithranol supplier.
PharmaCompass also assists you with knowing the Dithranol API Price utilized in the formulation of products. Dithranol API Price is not always fixed or binding as the Dithranol Price is obtained through a variety of data sources. The Dithranol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dithranol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dithranol, including repackagers and relabelers. The FDA regulates Dithranol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dithranol 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 Dithranol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dithranol supplier is an individual or a company that provides Dithranol active pharmaceutical ingredient (API) or Dithranol finished formulations upon request. The Dithranol suppliers may include Dithranol API manufacturers, exporters, distributors and traders.
click here to find a list of Dithranol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dithranol CEP of the European Pharmacopoeia monograph is often referred to as a Dithranol Certificate of Suitability (COS). The purpose of a Dithranol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dithranol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dithranol to their clients by showing that a Dithranol CEP has been issued for it. The manufacturer submits a Dithranol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dithranol CEP holder for the record. Additionally, the data presented in the Dithranol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dithranol DMF.
A Dithranol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dithranol 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 Dithranol suppliers with CEP (COS) on PharmaCompass.
A Dithranol written confirmation (Dithranol WC) is an official document issued by a regulatory agency to a Dithranol manufacturer, verifying that the manufacturing facility of a Dithranol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dithranol APIs or Dithranol finished pharmaceutical products to another nation, regulatory agencies frequently require a Dithranol WC (written confirmation) as part of the regulatory process.
click here to find a list of Dithranol 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 Dithranol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dithranol 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 Dithranol 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 Dithranol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dithranol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dithranol suppliers with NDC on PharmaCompass.
Dithranol 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 Dithranol 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 Dithranol GMP manufacturer or Dithranol GMP API supplier for your needs.
A Dithranol CoA (Certificate of Analysis) is a formal document that attests to Dithranol's compliance with Dithranol specifications and serves as a tool for batch-level quality control.
Dithranol CoA mostly includes findings from lab analyses of a specific batch. For each Dithranol 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.
Dithranol may be tested according to a variety of international standards, such as European Pharmacopoeia (Dithranol EP), Dithranol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dithranol USP).