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ABOUT THIS PAGE
A Iopromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iopromide, including repackagers and relabelers. The FDA regulates Iopromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iopromide 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 Iopromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iopromide supplier is an individual or a company that provides Iopromide active pharmaceutical ingredient (API) or Iopromide finished formulations upon request. The Iopromide suppliers may include Iopromide API manufacturers, exporters, distributors and traders.
click here to find a list of Iopromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iopromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Iopromide active pharmaceutical ingredient (API) in detail. Different forms of Iopromide DMFs exist exist since differing nations have different regulations, such as Iopromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iopromide DMF submitted to regulatory agencies in the US is known as a USDMF. Iopromide USDMF includes data on Iopromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iopromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iopromide 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 Iopromide Drug Master File in Japan (Iopromide JDMF) empowers Iopromide 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 Iopromide JDMF during the approval evaluation for pharmaceutical products. At the time of Iopromide 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 Iopromide 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 Iopromide Drug Master File in Korea (Iopromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iopromide. The MFDS reviews the Iopromide KDMF as part of the drug registration process and uses the information provided in the Iopromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iopromide 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 Iopromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iopromide suppliers with KDMF on PharmaCompass.
A Iopromide CEP of the European Pharmacopoeia monograph is often referred to as a Iopromide Certificate of Suitability (COS). The purpose of a Iopromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Iopromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Iopromide to their clients by showing that a Iopromide CEP has been issued for it. The manufacturer submits a Iopromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Iopromide CEP holder for the record. Additionally, the data presented in the Iopromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Iopromide DMF.
A Iopromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Iopromide 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 Iopromide suppliers with CEP (COS) on PharmaCompass.
A Iopromide written confirmation (Iopromide WC) is an official document issued by a regulatory agency to a Iopromide manufacturer, verifying that the manufacturing facility of a Iopromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Iopromide APIs or Iopromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Iopromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Iopromide suppliers with Written Confirmation (WC) on PharmaCompass.
Iopromide 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 Iopromide 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 Iopromide GMP manufacturer or Iopromide GMP API supplier for your needs.
A Iopromide CoA (Certificate of Analysis) is a formal document that attests to Iopromide's compliance with Iopromide specifications and serves as a tool for batch-level quality control.
Iopromide CoA mostly includes findings from lab analyses of a specific batch. For each Iopromide 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.
Iopromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Iopromide EP), Iopromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iopromide USP).
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