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API SUPPLIERS
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
PI Health Sciences: Biotech for Hire providing end-to-end discovery and development powered by chemistry, biology, and AI.
Minakem is manufacturing small molecules APIs including corticosteroids
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
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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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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...
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REF. STANDARDS & IMPURITIES
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 Salicylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Choline Salicylate, including repackagers and relabelers. The FDA regulates Choline Salicylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Choline Salicylate 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 Salicylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Choline Salicylate supplier is an individual or a company that provides Choline Salicylate active pharmaceutical ingredient (API) or Choline Salicylate finished formulations upon request. The Choline Salicylate suppliers may include Choline Salicylate API manufacturers, exporters, distributors and traders.
click here to find a list of Choline Salicylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Choline Salicylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Choline Salicylate active pharmaceutical ingredient (API) in detail. Different forms of Choline Salicylate DMFs exist exist since differing nations have different regulations, such as Choline Salicylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Choline Salicylate DMF submitted to regulatory agencies in the US is known as a USDMF. Choline Salicylate USDMF includes data on Choline Salicylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Choline Salicylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Choline Salicylate 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 Salicylate Drug Master File in Japan (Choline Salicylate JDMF) empowers Choline Salicylate 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 Salicylate JDMF during the approval evaluation for pharmaceutical products. At the time of Choline Salicylate 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 Salicylate 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 Salicylate Drug Master File in Korea (Choline Salicylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Choline Salicylate. The MFDS reviews the Choline Salicylate KDMF as part of the drug registration process and uses the information provided in the Choline Salicylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Choline Salicylate 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 Salicylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Choline Salicylate suppliers with KDMF on PharmaCompass.
A Choline Salicylate written confirmation (Choline Salicylate WC) is an official document issued by a regulatory agency to a Choline Salicylate manufacturer, verifying that the manufacturing facility of a Choline Salicylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Choline Salicylate APIs or Choline Salicylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Choline Salicylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Choline Salicylate 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 Salicylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Choline Salicylate 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 Salicylate 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 Salicylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Choline Salicylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Choline Salicylate suppliers with NDC on PharmaCompass.
Choline Salicylate 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 Salicylate 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 Salicylate GMP manufacturer or Choline Salicylate GMP API supplier for your needs.
A Choline Salicylate CoA (Certificate of Analysis) is a formal document that attests to Choline Salicylate's compliance with Choline Salicylate specifications and serves as a tool for batch-level quality control.
Choline Salicylate CoA mostly includes findings from lab analyses of a specific batch. For each Choline Salicylate 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 Salicylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Choline Salicylate EP), Choline Salicylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Choline Salicylate USP).
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