Synopsis
0
JDMF
0
VMF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
43
PharmaCompass offers a list of Diacerein 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 Diacerein manufacturer or Diacerein supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diacerein manufacturer or Diacerein supplier.
PharmaCompass also assists you with knowing the Diacerein API Price utilized in the formulation of products. Diacerein API Price is not always fixed or binding as the Diacerein Price is obtained through a variety of data sources. The Diacerein Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Diacerein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diacerein, including repackagers and relabelers. The FDA regulates Diacerein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diacerein 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 Diacerein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diacerein supplier is an individual or a company that provides Diacerein active pharmaceutical ingredient (API) or Diacerein finished formulations upon request. The Diacerein suppliers may include Diacerein API manufacturers, exporters, distributors and traders.
click here to find a list of Diacerein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diacerein DMF (Drug Master File) is a document detailing the whole manufacturing process of Diacerein active pharmaceutical ingredient (API) in detail. Different forms of Diacerein DMFs exist exist since differing nations have different regulations, such as Diacerein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diacerein DMF submitted to regulatory agencies in the US is known as a USDMF. Diacerein USDMF includes data on Diacerein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diacerein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diacerein 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 Diacerein Drug Master File in Korea (Diacerein KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diacerein. The MFDS reviews the Diacerein KDMF as part of the drug registration process and uses the information provided in the Diacerein KDMF to evaluate the safety and efficacy of the drug.
After submitting a Diacerein 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 Diacerein API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Diacerein suppliers with KDMF on PharmaCompass.
A Diacerein CEP of the European Pharmacopoeia monograph is often referred to as a Diacerein Certificate of Suitability (COS). The purpose of a Diacerein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Diacerein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Diacerein to their clients by showing that a Diacerein CEP has been issued for it. The manufacturer submits a Diacerein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Diacerein CEP holder for the record. Additionally, the data presented in the Diacerein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Diacerein DMF.
A Diacerein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diacerein 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 Diacerein suppliers with CEP (COS) on PharmaCompass.
A Diacerein written confirmation (Diacerein WC) is an official document issued by a regulatory agency to a Diacerein manufacturer, verifying that the manufacturing facility of a Diacerein active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Diacerein APIs or Diacerein finished pharmaceutical products to another nation, regulatory agencies frequently require a Diacerein WC (written confirmation) as part of the regulatory process.
click here to find a list of Diacerein 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 Diacerein as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diacerein 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 Diacerein 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 Diacerein and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diacerein NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diacerein suppliers with NDC on PharmaCompass.
Diacerein 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 Diacerein 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 Diacerein GMP manufacturer or Diacerein GMP API supplier for your needs.
A Diacerein CoA (Certificate of Analysis) is a formal document that attests to Diacerein's compliance with Diacerein specifications and serves as a tool for batch-level quality control.
Diacerein CoA mostly includes findings from lab analyses of a specific batch. For each Diacerein 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.
Diacerein may be tested according to a variety of international standards, such as European Pharmacopoeia (Diacerein EP), Diacerein JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diacerein USP).
