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