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