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ABOUT THIS PAGE
A Metadoxine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metadoxine, including repackagers and relabelers. The FDA regulates Metadoxine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metadoxine 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 Metadoxine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Metadoxine supplier is an individual or a company that provides Metadoxine active pharmaceutical ingredient (API) or Metadoxine finished formulations upon request. The Metadoxine suppliers may include Metadoxine API manufacturers, exporters, distributors and traders.
click here to find a list of Metadoxine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Metadoxine Drug Master File in Korea (Metadoxine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Metadoxine. The MFDS reviews the Metadoxine KDMF as part of the drug registration process and uses the information provided in the Metadoxine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Metadoxine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Metadoxine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Metadoxine suppliers with KDMF on PharmaCompass.
A Metadoxine written confirmation (Metadoxine WC) is an official document issued by a regulatory agency to a Metadoxine manufacturer, verifying that the manufacturing facility of a Metadoxine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Metadoxine APIs or Metadoxine finished pharmaceutical products to another nation, regulatory agencies frequently require a Metadoxine WC (written confirmation) as part of the regulatory process.
click here to find a list of Metadoxine suppliers with Written Confirmation (WC) on PharmaCompass.
Metadoxine 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 Metadoxine 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 Metadoxine GMP manufacturer or Metadoxine GMP API supplier for your needs.
A Metadoxine CoA (Certificate of Analysis) is a formal document that attests to Metadoxine's compliance with Metadoxine specifications and serves as a tool for batch-level quality control.
Metadoxine CoA mostly includes findings from lab analyses of a specific batch. For each Metadoxine 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.
Metadoxine may be tested according to a variety of international standards, such as European Pharmacopoeia (Metadoxine EP), Metadoxine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Metadoxine USP).
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