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