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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 203341
DOSAGE - TABLET;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 203341
DOSAGE - TABLET;ORAL - EQ 500MG BASE
USFDA APPLICATION NUMBER - 203341
DOSAGE - CAPSULE;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 217729
DOSAGE - CAPSULE;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 217729
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ABOUT THIS PAGE
A Bosutinib Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosutinib Monohydrate, including repackagers and relabelers. The FDA regulates Bosutinib Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosutinib Monohydrate 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 Bosutinib Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bosutinib Monohydrate supplier is an individual or a company that provides Bosutinib Monohydrate active pharmaceutical ingredient (API) or Bosutinib Monohydrate finished formulations upon request. The Bosutinib Monohydrate suppliers may include Bosutinib Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bosutinib Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bosutinib Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bosutinib Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Bosutinib Monohydrate DMFs exist exist since differing nations have different regulations, such as Bosutinib Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bosutinib Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Bosutinib Monohydrate USDMF includes data on Bosutinib Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bosutinib Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bosutinib Monohydrate suppliers with USDMF 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 Bosutinib Monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bosutinib Monohydrate 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 Bosutinib Monohydrate 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 Bosutinib Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bosutinib Monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bosutinib Monohydrate suppliers with NDC on PharmaCompass.
Bosutinib Monohydrate 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 Bosutinib Monohydrate 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 Bosutinib Monohydrate GMP manufacturer or Bosutinib Monohydrate GMP API supplier for your needs.
A Bosutinib Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Bosutinib Monohydrate's compliance with Bosutinib Monohydrate specifications and serves as a tool for batch-level quality control.
Bosutinib Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Bosutinib Monohydrate 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.
Bosutinib Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Bosutinib Monohydrate EP), Bosutinib Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bosutinib Monohydrate USP).
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