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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cladribine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cladribine, including repackagers and relabelers. The FDA regulates Cladribine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cladribine 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 Cladribine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cladribine supplier is an individual or a company that provides Cladribine active pharmaceutical ingredient (API) or Cladribine finished formulations upon request. The Cladribine suppliers may include Cladribine API manufacturers, exporters, distributors and traders.
click here to find a list of Cladribine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cladribine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cladribine active pharmaceutical ingredient (API) in detail. Different forms of Cladribine DMFs exist exist since differing nations have different regulations, such as Cladribine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cladribine DMF submitted to regulatory agencies in the US is known as a USDMF. Cladribine USDMF includes data on Cladribine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cladribine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cladribine 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 Cladribine Drug Master File in Japan (Cladribine JDMF) empowers Cladribine 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 Cladribine JDMF during the approval evaluation for pharmaceutical products. At the time of Cladribine 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 Cladribine suppliers with JDMF on PharmaCompass.
A Cladribine CEP of the European Pharmacopoeia monograph is often referred to as a Cladribine Certificate of Suitability (COS). The purpose of a Cladribine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cladribine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cladribine to their clients by showing that a Cladribine CEP has been issued for it. The manufacturer submits a Cladribine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cladribine CEP holder for the record. Additionally, the data presented in the Cladribine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cladribine DMF.
A Cladribine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cladribine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cladribine suppliers with CEP (COS) on PharmaCompass.
A Cladribine written confirmation (Cladribine WC) is an official document issued by a regulatory agency to a Cladribine manufacturer, verifying that the manufacturing facility of a Cladribine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cladribine APIs or Cladribine finished pharmaceutical products to another nation, regulatory agencies frequently require a Cladribine WC (written confirmation) as part of the regulatory process.
click here to find a list of Cladribine 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 Cladribine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cladribine 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 Cladribine 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 Cladribine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cladribine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cladribine suppliers with NDC on PharmaCompass.
Cladribine 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 Cladribine 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 Cladribine GMP manufacturer or Cladribine GMP API supplier for your needs.
A Cladribine CoA (Certificate of Analysis) is a formal document that attests to Cladribine's compliance with Cladribine specifications and serves as a tool for batch-level quality control.
Cladribine CoA mostly includes findings from lab analyses of a specific batch. For each Cladribine 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.
Cladribine may be tested according to a variety of international standards, such as European Pharmacopoeia (Cladribine EP), Cladribine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cladribine USP).
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