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DOSAGE - INJECTABLE;INJECTION - 41%
USFDA APPLICATION NUMBER - 18735
DOSAGE - INJECTABLE;INJECTION - 51%
USFDA APPLICATION NUMBER - 18735
DOSAGE - INJECTABLE;INJECTION - 61%
USFDA APPLICATION NUMBER - 18735
DOSAGE - INJECTABLE;INJECTION - 76%
USFDA APPLICATION NUMBER - 18735
DOSAGE - INJECTABLE;INJECTION - 51%
USFDA APPLICATION NUMBER - 20327
DOSAGE - INJECTABLE;INJECTION - 61%
USFDA APPLICATION NUMBER - 20327
DOSAGE - INJECTABLE;INJECTION - 76%
USFDA APPLICATION NUMBER - 20327
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Iopamidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iopamidol, including repackagers and relabelers. The FDA regulates Iopamidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iopamidol 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 Iopamidol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iopamidol supplier is an individual or a company that provides Iopamidol active pharmaceutical ingredient (API) or Iopamidol finished formulations upon request. The Iopamidol suppliers may include Iopamidol API manufacturers, exporters, distributors and traders.
click here to find a list of Iopamidol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iopamidol DMF (Drug Master File) is a document detailing the whole manufacturing process of Iopamidol active pharmaceutical ingredient (API) in detail. Different forms of Iopamidol DMFs exist exist since differing nations have different regulations, such as Iopamidol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iopamidol DMF submitted to regulatory agencies in the US is known as a USDMF. Iopamidol USDMF includes data on Iopamidol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iopamidol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iopamidol 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 Iopamidol Drug Master File in Japan (Iopamidol JDMF) empowers Iopamidol 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 Iopamidol JDMF during the approval evaluation for pharmaceutical products. At the time of Iopamidol 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 Iopamidol 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 Iopamidol Drug Master File in Korea (Iopamidol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iopamidol. The MFDS reviews the Iopamidol KDMF as part of the drug registration process and uses the information provided in the Iopamidol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iopamidol 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 Iopamidol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iopamidol suppliers with KDMF on PharmaCompass.
A Iopamidol CEP of the European Pharmacopoeia monograph is often referred to as a Iopamidol Certificate of Suitability (COS). The purpose of a Iopamidol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Iopamidol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Iopamidol to their clients by showing that a Iopamidol CEP has been issued for it. The manufacturer submits a Iopamidol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Iopamidol CEP holder for the record. Additionally, the data presented in the Iopamidol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Iopamidol DMF.
A Iopamidol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Iopamidol 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 Iopamidol suppliers with CEP (COS) on PharmaCompass.
A Iopamidol written confirmation (Iopamidol WC) is an official document issued by a regulatory agency to a Iopamidol manufacturer, verifying that the manufacturing facility of a Iopamidol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Iopamidol APIs or Iopamidol finished pharmaceutical products to another nation, regulatory agencies frequently require a Iopamidol WC (written confirmation) as part of the regulatory process.
click here to find a list of Iopamidol 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 Iopamidol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Iopamidol 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 Iopamidol 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 Iopamidol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Iopamidol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Iopamidol suppliers with NDC on PharmaCompass.
Iopamidol 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 Iopamidol 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 Iopamidol GMP manufacturer or Iopamidol GMP API supplier for your needs.
A Iopamidol CoA (Certificate of Analysis) is a formal document that attests to Iopamidol's compliance with Iopamidol specifications and serves as a tool for batch-level quality control.
Iopamidol CoA mostly includes findings from lab analyses of a specific batch. For each Iopamidol 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.
Iopamidol may be tested according to a variety of international standards, such as European Pharmacopoeia (Iopamidol EP), Iopamidol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iopamidol USP).
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