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