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API SUPPLIERS
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
PI Health Sciences: Biotech for Hire providing end-to-end discovery and development powered by chemistry, biology, and AI.
About the Company : PI Health Sciences offers end-to-end drug discovery and development, integrating medicinal chemistry, synthetic chemistry, biology, and AI-driven technologies. Its co-located teams...
Minakem is manufacturing small molecules APIs including corticosteroids
About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Film Formers & Plasticizers
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ABOUT THIS PAGE
77
PharmaCompass offers a list of Choline 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 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.
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, and COA 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, and COA 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.
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, 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).
