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ABOUT THIS PAGE
A Meldonium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meldonium, including repackagers and relabelers. The FDA regulates Meldonium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meldonium 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 Meldonium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meldonium supplier is an individual or a company that provides Meldonium active pharmaceutical ingredient (API) or Meldonium finished formulations upon request. The Meldonium suppliers may include Meldonium API manufacturers, exporters, distributors and traders.
click here to find a list of Meldonium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meldonium CEP of the European Pharmacopoeia monograph is often referred to as a Meldonium Certificate of Suitability (COS). The purpose of a Meldonium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meldonium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meldonium to their clients by showing that a Meldonium CEP has been issued for it. The manufacturer submits a Meldonium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meldonium CEP holder for the record. Additionally, the data presented in the Meldonium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meldonium DMF.
A Meldonium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meldonium 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 Meldonium suppliers with CEP (COS) on PharmaCompass.
A Meldonium written confirmation (Meldonium WC) is an official document issued by a regulatory agency to a Meldonium manufacturer, verifying that the manufacturing facility of a Meldonium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Meldonium APIs or Meldonium finished pharmaceutical products to another nation, regulatory agencies frequently require a Meldonium WC (written confirmation) as part of the regulatory process.
click here to find a list of Meldonium suppliers with Written Confirmation (WC) on PharmaCompass.
Meldonium 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 Meldonium 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 Meldonium GMP manufacturer or Meldonium GMP API supplier for your needs.
A Meldonium CoA (Certificate of Analysis) is a formal document that attests to Meldonium's compliance with Meldonium specifications and serves as a tool for batch-level quality control.
Meldonium CoA mostly includes findings from lab analyses of a specific batch. For each Meldonium 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.
Meldonium may be tested according to a variety of international standards, such as European Pharmacopoeia (Meldonium EP), Meldonium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meldonium USP).
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