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