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USDMF
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7329
Submission : 1988-02-12
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Choline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Choline manufacturer or Choline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Choline manufacturer or Choline supplier.
PharmaCompass also assists you with knowing the Choline API Price utilized in the formulation of products. Choline API Price is not always fixed or binding as the Choline Price is obtained through a variety of data sources. The Choline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Choline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Choline, including repackagers and relabelers. The FDA regulates Choline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Choline 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 Choline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Choline supplier is an individual or a company that provides Choline active pharmaceutical ingredient (API) or Choline finished formulations upon request. The Choline suppliers may include Choline API manufacturers, exporters, distributors and traders.
click here to find a list of Choline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Choline DMF (Drug Master File) is a document detailing the whole manufacturing process of Choline active pharmaceutical ingredient (API) in detail. Different forms of Choline DMFs exist exist since differing nations have different regulations, such as Choline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Choline DMF submitted to regulatory agencies in the US is known as a USDMF. Choline USDMF includes data on Choline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Choline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Choline 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 Choline Drug Master File in Japan (Choline JDMF) empowers Choline 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 Choline JDMF during the approval evaluation for pharmaceutical products. At the time of Choline 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 Choline suppliers with JDMF 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 Choline Drug Master File in Korea (Choline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Choline. The MFDS reviews the Choline KDMF as part of the drug registration process and uses the information provided in the Choline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Choline 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 Choline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Choline suppliers with KDMF on PharmaCompass.
A Choline written confirmation (Choline WC) is an official document issued by a regulatory agency to a Choline manufacturer, verifying that the manufacturing facility of a Choline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Choline APIs or Choline finished pharmaceutical products to another nation, regulatory agencies frequently require a Choline WC (written confirmation) as part of the regulatory process.
click here to find a list of Choline 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 Choline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Choline 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 Choline 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 Choline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Choline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Choline suppliers with NDC on PharmaCompass.
Choline 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 Choline 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 Choline GMP manufacturer or Choline GMP API supplier for your needs.
A Choline CoA (Certificate of Analysis) is a formal document that attests to Choline's compliance with Choline specifications and serves as a tool for batch-level quality control.
Choline CoA mostly includes findings from lab analyses of a specific batch. For each Choline 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.
Choline may be tested according to a variety of international standards, such as European Pharmacopoeia (Choline EP), Choline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Choline USP).
