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