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PharmaCompass offers a list of Gadoterate Meglumine 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 Gadoterate Meglumine manufacturer or Gadoterate Meglumine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadoterate Meglumine manufacturer or Gadoterate Meglumine supplier.
PharmaCompass also assists you with knowing the Gadoterate Meglumine API Price utilized in the formulation of products. Gadoterate Meglumine API Price is not always fixed or binding as the Gadoterate Meglumine Price is obtained through a variety of data sources. The Gadoterate Meglumine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gd-DOTA Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gd-DOTA Meglumine, including repackagers and relabelers. The FDA regulates Gd-DOTA Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gd-DOTA Meglumine 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 Gd-DOTA Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gd-DOTA Meglumine supplier is an individual or a company that provides Gd-DOTA Meglumine active pharmaceutical ingredient (API) or Gd-DOTA Meglumine finished formulations upon request. The Gd-DOTA Meglumine suppliers may include Gd-DOTA Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Gd-DOTA Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gd-DOTA Meglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Gd-DOTA Meglumine active pharmaceutical ingredient (API) in detail. Different forms of Gd-DOTA Meglumine DMFs exist exist since differing nations have different regulations, such as Gd-DOTA Meglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gd-DOTA Meglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Gd-DOTA Meglumine USDMF includes data on Gd-DOTA Meglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gd-DOTA Meglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gd-DOTA Meglumine suppliers with USDMF 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 Gd-DOTA Meglumine Drug Master File in Korea (Gd-DOTA Meglumine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gd-DOTA Meglumine. The MFDS reviews the Gd-DOTA Meglumine KDMF as part of the drug registration process and uses the information provided in the Gd-DOTA Meglumine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gd-DOTA Meglumine 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 Gd-DOTA Meglumine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gd-DOTA Meglumine suppliers with KDMF on PharmaCompass.
A Gd-DOTA Meglumine written confirmation (Gd-DOTA Meglumine WC) is an official document issued by a regulatory agency to a Gd-DOTA Meglumine manufacturer, verifying that the manufacturing facility of a Gd-DOTA Meglumine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gd-DOTA Meglumine APIs or Gd-DOTA Meglumine finished pharmaceutical products to another nation, regulatory agencies frequently require a Gd-DOTA Meglumine WC (written confirmation) as part of the regulatory process.
click here to find a list of Gd-DOTA Meglumine 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 Gd-DOTA Meglumine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gd-DOTA Meglumine 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 Gd-DOTA Meglumine 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 Gd-DOTA Meglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gd-DOTA Meglumine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gd-DOTA Meglumine suppliers with NDC on PharmaCompass.
Gd-DOTA Meglumine 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 Gd-DOTA Meglumine 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 Gd-DOTA Meglumine GMP manufacturer or Gd-DOTA Meglumine GMP API supplier for your needs.
A Gd-DOTA Meglumine CoA (Certificate of Analysis) is a formal document that attests to Gd-DOTA Meglumine's compliance with Gd-DOTA Meglumine specifications and serves as a tool for batch-level quality control.
Gd-DOTA Meglumine CoA mostly includes findings from lab analyses of a specific batch. For each Gd-DOTA Meglumine 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.
Gd-DOTA Meglumine may be tested according to a variety of international standards, such as European Pharmacopoeia (Gd-DOTA Meglumine EP), Gd-DOTA Meglumine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gd-DOTA Meglumine USP).
