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