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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Decitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Decitabine, including repackagers and relabelers. The FDA regulates Decitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Decitabine 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 Decitabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Decitabine supplier is an individual or a company that provides Decitabine active pharmaceutical ingredient (API) or Decitabine finished formulations upon request. The Decitabine suppliers may include Decitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Decitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Decitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Decitabine active pharmaceutical ingredient (API) in detail. Different forms of Decitabine DMFs exist exist since differing nations have different regulations, such as Decitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Decitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Decitabine USDMF includes data on Decitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Decitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Decitabine 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 Decitabine Drug Master File in Korea (Decitabine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Decitabine. The MFDS reviews the Decitabine KDMF as part of the drug registration process and uses the information provided in the Decitabine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Decitabine 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 Decitabine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Decitabine suppliers with KDMF on PharmaCompass.
A Decitabine written confirmation (Decitabine WC) is an official document issued by a regulatory agency to a Decitabine manufacturer, verifying that the manufacturing facility of a Decitabine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Decitabine APIs or Decitabine finished pharmaceutical products to another nation, regulatory agencies frequently require a Decitabine WC (written confirmation) as part of the regulatory process.
click here to find a list of Decitabine 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 Decitabine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Decitabine 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 Decitabine 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 Decitabine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Decitabine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Decitabine suppliers with NDC on PharmaCompass.
Decitabine 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 Decitabine 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 Decitabine GMP manufacturer or Decitabine GMP API supplier for your needs.
A Decitabine CoA (Certificate of Analysis) is a formal document that attests to Decitabine's compliance with Decitabine specifications and serves as a tool for batch-level quality control.
Decitabine CoA mostly includes findings from lab analyses of a specific batch. For each Decitabine 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.
Decitabine may be tested according to a variety of international standards, such as European Pharmacopoeia (Decitabine EP), Decitabine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Decitabine USP).
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