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