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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
USFDA APPLICATION NUMBER - 18920
DOSAGE - SOLUTION;INTRAVENOUS - 25,000MG/50ML...DOSAGE - SOLUTION;INTRAVENOUS - 25,000MG/50ML (500MG/ML)
USFDA APPLICATION NUMBER - 209112
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
USFDA APPLICATION NUMBER - 21625
DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
USFDA APPLICATION NUMBER - 8809
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EUROAPI
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REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
72
PharmaCompass offers a list of Ascorbic Acid 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 Ascorbic Acid manufacturer or Ascorbic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ascorbic Acid manufacturer or Ascorbic Acid supplier.
PharmaCompass also assists you with knowing the Ascorbic Acid API Price utilized in the formulation of products. Ascorbic Acid API Price is not always fixed or binding as the Ascorbic Acid Price is obtained through a variety of data sources. The Ascorbic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cebion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cebion, including repackagers and relabelers. The FDA regulates Cebion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cebion 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 Cebion manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cebion supplier is an individual or a company that provides Cebion active pharmaceutical ingredient (API) or Cebion finished formulations upon request. The Cebion suppliers may include Cebion API manufacturers, exporters, distributors and traders.
click here to find a list of Cebion suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cebion DMF (Drug Master File) is a document detailing the whole manufacturing process of Cebion active pharmaceutical ingredient (API) in detail. Different forms of Cebion DMFs exist exist since differing nations have different regulations, such as Cebion USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cebion DMF submitted to regulatory agencies in the US is known as a USDMF. Cebion USDMF includes data on Cebion's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cebion USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cebion 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 Cebion Drug Master File in Japan (Cebion JDMF) empowers Cebion 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 Cebion JDMF during the approval evaluation for pharmaceutical products. At the time of Cebion 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 Cebion 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 Cebion Drug Master File in Korea (Cebion KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cebion. The MFDS reviews the Cebion KDMF as part of the drug registration process and uses the information provided in the Cebion KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cebion 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 Cebion API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cebion suppliers with KDMF on PharmaCompass.
A Cebion CEP of the European Pharmacopoeia monograph is often referred to as a Cebion Certificate of Suitability (COS). The purpose of a Cebion CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cebion EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cebion to their clients by showing that a Cebion CEP has been issued for it. The manufacturer submits a Cebion CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cebion CEP holder for the record. Additionally, the data presented in the Cebion CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cebion DMF.
A Cebion CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cebion CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cebion suppliers with CEP (COS) on PharmaCompass.
A Cebion written confirmation (Cebion WC) is an official document issued by a regulatory agency to a Cebion manufacturer, verifying that the manufacturing facility of a Cebion active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cebion APIs or Cebion finished pharmaceutical products to another nation, regulatory agencies frequently require a Cebion WC (written confirmation) as part of the regulatory process.
click here to find a list of Cebion 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 Cebion as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cebion 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 Cebion 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 Cebion and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cebion NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cebion suppliers with NDC on PharmaCompass.
Cebion 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 Cebion 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 Cebion GMP manufacturer or Cebion GMP API supplier for your needs.
A Cebion CoA (Certificate of Analysis) is a formal document that attests to Cebion's compliance with Cebion specifications and serves as a tool for batch-level quality control.
Cebion CoA mostly includes findings from lab analyses of a specific batch. For each Cebion 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.
Cebion may be tested according to a variety of international standards, such as European Pharmacopoeia (Cebion EP), Cebion JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cebion USP).
