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