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PharmaCompass offers a list of Dasatinib 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 Dasatinib manufacturer or Dasatinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dasatinib manufacturer or Dasatinib supplier.
PharmaCompass also assists you with knowing the Dasatinib API Price utilized in the formulation of products. Dasatinib API Price is not always fixed or binding as the Dasatinib Price is obtained through a variety of data sources. The Dasatinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dasatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dasatinib, including repackagers and relabelers. The FDA regulates Dasatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dasatinib 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 Dasatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dasatinib supplier is an individual or a company that provides Dasatinib active pharmaceutical ingredient (API) or Dasatinib finished formulations upon request. The Dasatinib suppliers may include Dasatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Dasatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dasatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Dasatinib active pharmaceutical ingredient (API) in detail. Different forms of Dasatinib DMFs exist exist since differing nations have different regulations, such as Dasatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dasatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Dasatinib USDMF includes data on Dasatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dasatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dasatinib suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Dasatinib Drug Master File in Japan (Dasatinib JDMF) empowers Dasatinib API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Dasatinib JDMF during the approval evaluation for pharmaceutical products. At the time of Dasatinib JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Dasatinib suppliers with JDMF 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 Dasatinib Drug Master File in Korea (Dasatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dasatinib. The MFDS reviews the Dasatinib KDMF as part of the drug registration process and uses the information provided in the Dasatinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dasatinib 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 Dasatinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dasatinib suppliers with KDMF on PharmaCompass.
A Dasatinib written confirmation (Dasatinib WC) is an official document issued by a regulatory agency to a Dasatinib manufacturer, verifying that the manufacturing facility of a Dasatinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dasatinib APIs or Dasatinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Dasatinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Dasatinib 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 Dasatinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dasatinib 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 Dasatinib 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 Dasatinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dasatinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dasatinib suppliers with NDC on PharmaCompass.
Dasatinib 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 Dasatinib 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 Dasatinib GMP manufacturer or Dasatinib GMP API supplier for your needs.
A Dasatinib CoA (Certificate of Analysis) is a formal document that attests to Dasatinib's compliance with Dasatinib specifications and serves as a tool for batch-level quality control.
Dasatinib CoA mostly includes findings from lab analyses of a specific batch. For each Dasatinib 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.
Dasatinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Dasatinib EP), Dasatinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dasatinib USP).