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PharmaCompass offers a list of Citicoline Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Citicoline Sodium manufacturer or Citicoline Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Citicoline Sodium manufacturer or Citicoline Sodium supplier.
A Citicoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Citicoline, including repackagers and relabelers. The FDA regulates Citicoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Citicoline 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 Citicoline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Citicoline supplier is an individual or a company that provides Citicoline active pharmaceutical ingredient (API) or Citicoline finished formulations upon request. The Citicoline suppliers may include Citicoline API manufacturers, exporters, distributors and traders.
click here to find a list of Citicoline suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Citicoline DMF (Drug Master File) is a document detailing the whole manufacturing process of Citicoline active pharmaceutical ingredient (API) in detail. Different forms of Citicoline DMFs exist exist since differing nations have different regulations, such as Citicoline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Citicoline DMF submitted to regulatory agencies in the US is known as a USDMF. Citicoline USDMF includes data on Citicoline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Citicoline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Citicoline suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Citicoline Drug Master File in Japan (Citicoline JDMF) empowers Citicoline API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Citicoline JDMF during the approval evaluation for pharmaceutical products. At the time of Citicoline JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Citicoline suppliers with JDMF on PharmaCompass.
A Citicoline written confirmation (Citicoline WC) is an official document issued by a regulatory agency to a Citicoline manufacturer, verifying that the manufacturing facility of a Citicoline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Citicoline APIs or Citicoline finished pharmaceutical products to another nation, regulatory agencies frequently require a Citicoline WC (written confirmation) as part of the regulatory process.
click here to find a list of Citicoline suppliers with Written Confirmation (WC) on PharmaCompass.
Citicoline 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 Citicoline GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Citicoline GMP manufacturer or Citicoline GMP API supplier for your needs.
A Citicoline CoA (Certificate of Analysis) is a formal document that attests to Citicoline's compliance with Citicoline specifications and serves as a tool for batch-level quality control.
Citicoline CoA mostly includes findings from lab analyses of a specific batch. For each Citicoline 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.
Citicoline may be tested according to a variety of international standards, such as European Pharmacopoeia (Citicoline EP), Citicoline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Citicoline USP).
