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