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ABOUT THIS PAGE
A Copovidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copovidone, including repackagers and relabelers. The FDA regulates Copovidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copovidone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Copovidone supplier is an individual or a company that provides Copovidone active pharmaceutical ingredient (API) or Copovidone finished formulations upon request. The Copovidone suppliers may include Copovidone API manufacturers, exporters, distributors and traders.
click here to find a list of Copovidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Copovidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Copovidone active pharmaceutical ingredient (API) in detail. Different forms of Copovidone DMFs exist exist since differing nations have different regulations, such as Copovidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Copovidone DMF submitted to regulatory agencies in the US is known as a USDMF. Copovidone USDMF includes data on Copovidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copovidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Copovidone suppliers with USDMF on PharmaCompass.
A Copovidone CEP of the European Pharmacopoeia monograph is often referred to as a Copovidone Certificate of Suitability (COS). The purpose of a Copovidone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Copovidone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Copovidone to their clients by showing that a Copovidone CEP has been issued for it. The manufacturer submits a Copovidone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Copovidone CEP holder for the record. Additionally, the data presented in the Copovidone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Copovidone DMF.
A Copovidone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Copovidone 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 Copovidone suppliers with CEP (COS) on PharmaCompass.
Copovidone 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 Copovidone 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 Copovidone GMP manufacturer or Copovidone GMP API supplier for your needs.
A Copovidone CoA (Certificate of Analysis) is a formal document that attests to Copovidone's compliance with Copovidone specifications and serves as a tool for batch-level quality control.
Copovidone CoA mostly includes findings from lab analyses of a specific batch. For each Copovidone 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.
Copovidone may be tested according to a variety of international standards, such as European Pharmacopoeia (Copovidone EP), Copovidone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Copovidone USP).
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