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ABOUT THIS PAGE
A Iodixanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iodixanol, including repackagers and relabelers. The FDA regulates Iodixanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iodixanol 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 Iodixanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iodixanol supplier is an individual or a company that provides Iodixanol active pharmaceutical ingredient (API) or Iodixanol finished formulations upon request. The Iodixanol suppliers may include Iodixanol API manufacturers, exporters, distributors and traders.
click here to find a list of Iodixanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iodixanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Iodixanol active pharmaceutical ingredient (API) in detail. Different forms of Iodixanol DMFs exist exist since differing nations have different regulations, such as Iodixanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iodixanol DMF submitted to regulatory agencies in the US is known as a USDMF. Iodixanol USDMF includes data on Iodixanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iodixanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iodixanol 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 Iodixanol Drug Master File in Japan (Iodixanol JDMF) empowers Iodixanol 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 Iodixanol JDMF during the approval evaluation for pharmaceutical products. At the time of Iodixanol 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 Iodixanol 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 Iodixanol Drug Master File in Korea (Iodixanol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iodixanol. The MFDS reviews the Iodixanol KDMF as part of the drug registration process and uses the information provided in the Iodixanol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iodixanol 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 Iodixanol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iodixanol suppliers with KDMF on PharmaCompass.
A Iodixanol CEP of the European Pharmacopoeia monograph is often referred to as a Iodixanol Certificate of Suitability (COS). The purpose of a Iodixanol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Iodixanol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Iodixanol to their clients by showing that a Iodixanol CEP has been issued for it. The manufacturer submits a Iodixanol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Iodixanol CEP holder for the record. Additionally, the data presented in the Iodixanol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Iodixanol DMF.
A Iodixanol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Iodixanol 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 Iodixanol suppliers with CEP (COS) 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 Iodixanol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Iodixanol 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 Iodixanol 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 Iodixanol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Iodixanol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Iodixanol suppliers with NDC on PharmaCompass.
Iodixanol 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 Iodixanol 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 Iodixanol GMP manufacturer or Iodixanol GMP API supplier for your needs.
A Iodixanol CoA (Certificate of Analysis) is a formal document that attests to Iodixanol's compliance with Iodixanol specifications and serves as a tool for batch-level quality control.
Iodixanol CoA mostly includes findings from lab analyses of a specific batch. For each Iodixanol 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.
Iodixanol may be tested according to a variety of international standards, such as European Pharmacopoeia (Iodixanol EP), Iodixanol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iodixanol USP).
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