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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36148
Submission : 2021-07-29
Status :
Type : II
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API Imports and Exports
Drugs in Development
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
CAS Number : 294-90-6
End Use API : Gadoterate Meglumine
About The Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermed...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
CAS Number : 60239-18-1
End Use API : Gadoterate Meglumine
About The Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermed...
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APIs
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REF. STANDARDS & IMPURITIES
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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 Gadoterate Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadoterate Meglumine, including repackagers and relabelers. The FDA regulates Gadoterate Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadoterate 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 Gadoterate Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadoterate Meglumine supplier is an individual or a company that provides Gadoterate Meglumine active pharmaceutical ingredient (API) or Gadoterate Meglumine finished formulations upon request. The Gadoterate Meglumine suppliers may include Gadoterate Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Gadoterate Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadoterate Meglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadoterate Meglumine active pharmaceutical ingredient (API) in detail. Different forms of Gadoterate Meglumine DMFs exist exist since differing nations have different regulations, such as Gadoterate Meglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadoterate Meglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Gadoterate Meglumine USDMF includes data on Gadoterate Meglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadoterate Meglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadoterate 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 Gadoterate Meglumine Drug Master File in Korea (Gadoterate Meglumine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gadoterate Meglumine. The MFDS reviews the Gadoterate Meglumine KDMF as part of the drug registration process and uses the information provided in the Gadoterate Meglumine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gadoterate 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 Gadoterate Meglumine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gadoterate Meglumine suppliers with KDMF on PharmaCompass.
A Gadoterate Meglumine written confirmation (Gadoterate Meglumine WC) is an official document issued by a regulatory agency to a Gadoterate Meglumine manufacturer, verifying that the manufacturing facility of a Gadoterate Meglumine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gadoterate Meglumine APIs or Gadoterate Meglumine finished pharmaceutical products to another nation, regulatory agencies frequently require a Gadoterate Meglumine WC (written confirmation) as part of the regulatory process.
click here to find a list of Gadoterate 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 Gadoterate Meglumine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gadoterate 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 Gadoterate 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 Gadoterate Meglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gadoterate Meglumine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gadoterate Meglumine suppliers with NDC on PharmaCompass.
Gadoterate 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 Gadoterate 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 Gadoterate Meglumine GMP manufacturer or Gadoterate Meglumine GMP API supplier for your needs.
A Gadoterate Meglumine CoA (Certificate of Analysis) is a formal document that attests to Gadoterate Meglumine's compliance with Gadoterate Meglumine specifications and serves as a tool for batch-level quality control.
Gadoterate Meglumine CoA mostly includes findings from lab analyses of a specific batch. For each Gadoterate 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.
Gadoterate Meglumine may be tested according to a variety of international standards, such as European Pharmacopoeia (Gadoterate Meglumine EP), Gadoterate Meglumine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gadoterate Meglumine USP).
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