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PharmaCompass offers a list of Gadobutrol 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 Gadobutrol manufacturer or Gadobutrol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadobutrol manufacturer or Gadobutrol supplier.
PharmaCompass also assists you with knowing the Gadobutrol API Price utilized in the formulation of products. Gadobutrol API Price is not always fixed or binding as the Gadobutrol Price is obtained through a variety of data sources. The Gadobutrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A gadolinium-DO3A-butriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gadolinium-DO3A-butriol, including repackagers and relabelers. The FDA regulates gadolinium-DO3A-butriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A gadolinium-DO3A-butriol supplier is an individual or a company that provides gadolinium-DO3A-butriol active pharmaceutical ingredient (API) or gadolinium-DO3A-butriol finished formulations upon request. The gadolinium-DO3A-butriol suppliers may include gadolinium-DO3A-butriol API manufacturers, exporters, distributors and traders.
click here to find a list of gadolinium-DO3A-butriol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A gadolinium-DO3A-butriol DMF (Drug Master File) is a document detailing the whole manufacturing process of gadolinium-DO3A-butriol active pharmaceutical ingredient (API) in detail. Different forms of gadolinium-DO3A-butriol DMFs exist exist since differing nations have different regulations, such as gadolinium-DO3A-butriol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A gadolinium-DO3A-butriol DMF submitted to regulatory agencies in the US is known as a USDMF. gadolinium-DO3A-butriol USDMF includes data on gadolinium-DO3A-butriol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The gadolinium-DO3A-butriol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol Drug Master File in Japan (gadolinium-DO3A-butriol JDMF) empowers gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol JDMF during the approval evaluation for pharmaceutical products. At the time of gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol Drug Master File in Korea (gadolinium-DO3A-butriol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of gadolinium-DO3A-butriol. The MFDS reviews the gadolinium-DO3A-butriol KDMF as part of the drug registration process and uses the information provided in the gadolinium-DO3A-butriol KDMF to evaluate the safety and efficacy of the drug.
After submitting a gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of gadolinium-DO3A-butriol suppliers with KDMF on PharmaCompass.
A gadolinium-DO3A-butriol CEP of the European Pharmacopoeia monograph is often referred to as a gadolinium-DO3A-butriol Certificate of Suitability (COS). The purpose of a gadolinium-DO3A-butriol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of gadolinium-DO3A-butriol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of gadolinium-DO3A-butriol to their clients by showing that a gadolinium-DO3A-butriol CEP has been issued for it. The manufacturer submits a gadolinium-DO3A-butriol CEP (COS) as part of the market authorization procedure, and it takes on the role of a gadolinium-DO3A-butriol CEP holder for the record. Additionally, the data presented in the gadolinium-DO3A-butriol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the gadolinium-DO3A-butriol DMF.
A gadolinium-DO3A-butriol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol suppliers with CEP (COS) on PharmaCompass.
A gadolinium-DO3A-butriol written confirmation (gadolinium-DO3A-butriol WC) is an official document issued by a regulatory agency to a gadolinium-DO3A-butriol manufacturer, verifying that the manufacturing facility of a gadolinium-DO3A-butriol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting gadolinium-DO3A-butriol APIs or gadolinium-DO3A-butriol finished pharmaceutical products to another nation, regulatory agencies frequently require a gadolinium-DO3A-butriol WC (written confirmation) as part of the regulatory process.
click here to find a list of gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a gadolinium-DO3A-butriol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of gadolinium-DO3A-butriol suppliers with NDC on PharmaCompass.
gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol GMP manufacturer or gadolinium-DO3A-butriol GMP API supplier for your needs.
A gadolinium-DO3A-butriol CoA (Certificate of Analysis) is a formal document that attests to gadolinium-DO3A-butriol's compliance with gadolinium-DO3A-butriol specifications and serves as a tool for batch-level quality control.
gadolinium-DO3A-butriol CoA mostly includes findings from lab analyses of a specific batch. For each gadolinium-DO3A-butriol 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.
gadolinium-DO3A-butriol may be tested according to a variety of international standards, such as European Pharmacopoeia (gadolinium-DO3A-butriol EP), gadolinium-DO3A-butriol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (gadolinium-DO3A-butriol USP).
