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PharmaCompass offers a list of Bosutinib 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 Bosutinib manufacturer or Bosutinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bosutinib manufacturer or Bosutinib supplier.
PharmaCompass also assists you with knowing the Bosutinib API Price utilized in the formulation of products. Bosutinib API Price is not always fixed or binding as the Bosutinib Price is obtained through a variety of data sources. The Bosutinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DB8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DB8, including repackagers and relabelers. The FDA regulates DB8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DB8 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 DB8 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DB8 supplier is an individual or a company that provides DB8 active pharmaceutical ingredient (API) or DB8 finished formulations upon request. The DB8 suppliers may include DB8 API manufacturers, exporters, distributors and traders.
click here to find a list of DB8 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DB8 DMF (Drug Master File) is a document detailing the whole manufacturing process of DB8 active pharmaceutical ingredient (API) in detail. Different forms of DB8 DMFs exist exist since differing nations have different regulations, such as DB8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DB8 DMF submitted to regulatory agencies in the US is known as a USDMF. DB8 USDMF includes data on DB8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DB8 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DB8 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 DB8 Drug Master File in Japan (DB8 JDMF) empowers DB8 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 DB8 JDMF during the approval evaluation for pharmaceutical products. At the time of DB8 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 DB8 suppliers with JDMF on PharmaCompass.
A DB8 written confirmation (DB8 WC) is an official document issued by a regulatory agency to a DB8 manufacturer, verifying that the manufacturing facility of a DB8 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DB8 APIs or DB8 finished pharmaceutical products to another nation, regulatory agencies frequently require a DB8 WC (written confirmation) as part of the regulatory process.
click here to find a list of DB8 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 DB8 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DB8 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 DB8 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 DB8 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DB8 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DB8 suppliers with NDC on PharmaCompass.
DB8 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 DB8 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 DB8 GMP manufacturer or DB8 GMP API supplier for your needs.
A DB8 CoA (Certificate of Analysis) is a formal document that attests to DB8's compliance with DB8 specifications and serves as a tool for batch-level quality control.
DB8 CoA mostly includes findings from lab analyses of a specific batch. For each DB8 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.
DB8 may be tested according to a variety of international standards, such as European Pharmacopoeia (DB8 EP), DB8 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DB8 USP).
