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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 33420
Submission : 2019-09-10
Status :
Type : II
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Pfanstiehl
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ABOUT THIS PAGE
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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 Gadovist manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadovist, including repackagers and relabelers. The FDA regulates Gadovist manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadovist 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 Gadovist manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadovist supplier is an individual or a company that provides Gadovist active pharmaceutical ingredient (API) or Gadovist finished formulations upon request. The Gadovist suppliers may include Gadovist API manufacturers, exporters, distributors and traders.
click here to find a list of Gadovist suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadovist DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadovist active pharmaceutical ingredient (API) in detail. Different forms of Gadovist DMFs exist exist since differing nations have different regulations, such as Gadovist USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadovist DMF submitted to regulatory agencies in the US is known as a USDMF. Gadovist USDMF includes data on Gadovist's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadovist USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadovist 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 Gadovist Drug Master File in Japan (Gadovist JDMF) empowers Gadovist 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 Gadovist JDMF during the approval evaluation for pharmaceutical products. At the time of Gadovist 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 Gadovist 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 Gadovist Drug Master File in Korea (Gadovist KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gadovist. The MFDS reviews the Gadovist KDMF as part of the drug registration process and uses the information provided in the Gadovist KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gadovist 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 Gadovist API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gadovist suppliers with KDMF on PharmaCompass.
A Gadovist CEP of the European Pharmacopoeia monograph is often referred to as a Gadovist Certificate of Suitability (COS). The purpose of a Gadovist CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gadovist EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gadovist to their clients by showing that a Gadovist CEP has been issued for it. The manufacturer submits a Gadovist CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gadovist CEP holder for the record. Additionally, the data presented in the Gadovist CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gadovist DMF.
A Gadovist CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gadovist 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 Gadovist suppliers with CEP (COS) on PharmaCompass.
A Gadovist written confirmation (Gadovist WC) is an official document issued by a regulatory agency to a Gadovist manufacturer, verifying that the manufacturing facility of a Gadovist active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gadovist APIs or Gadovist finished pharmaceutical products to another nation, regulatory agencies frequently require a Gadovist WC (written confirmation) as part of the regulatory process.
click here to find a list of Gadovist 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 Gadovist as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gadovist 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 Gadovist 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 Gadovist and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gadovist NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gadovist suppliers with NDC on PharmaCompass.
Gadovist 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 Gadovist 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 Gadovist GMP manufacturer or Gadovist GMP API supplier for your needs.
A Gadovist CoA (Certificate of Analysis) is a formal document that attests to Gadovist's compliance with Gadovist specifications and serves as a tool for batch-level quality control.
Gadovist CoA mostly includes findings from lab analyses of a specific batch. For each Gadovist 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.
Gadovist may be tested according to a variety of international standards, such as European Pharmacopoeia (Gadovist EP), Gadovist JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gadovist USP).
