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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
US Medicaid
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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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 : 2025-11-12
Pay. Date : 2025-09-17
DMF Number : 41810
Submission : 2025-07-31
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Pfanstiehl
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is used in electrophoresis, protein purification, enzyme assay, and as a buffering agent in biologics production.
Pharmacopoeia Ref : USP, EP, BP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Tromethamine
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Tris (hydroxymethyl) aminomethane is a buffering agent used in cell culture, downstream and biological formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Tromethamine
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14 Dec 2024
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ABOUT THIS PAGE
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PharmaCompass offers a list of Gadolinium Ethoxybenzyl Dtpa API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Gadolinium Ethoxybenzyl Dtpa manufacturer or Gadolinium Ethoxybenzyl Dtpa supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadolinium Ethoxybenzyl Dtpa manufacturer or Gadolinium Ethoxybenzyl Dtpa supplier.
A GADOXETATE DISODIUM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GADOXETATE DISODIUM, including repackagers and relabelers. The FDA regulates GADOXETATE DISODIUM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GADOXETATE DISODIUM 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 GADOXETATE DISODIUM manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A GADOXETATE DISODIUM supplier is an individual or a company that provides GADOXETATE DISODIUM active pharmaceutical ingredient (API) or GADOXETATE DISODIUM finished formulations upon request. The GADOXETATE DISODIUM suppliers may include GADOXETATE DISODIUM API manufacturers, exporters, distributors and traders.
click here to find a list of GADOXETATE DISODIUM suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A GADOXETATE DISODIUM DMF (Drug Master File) is a document detailing the whole manufacturing process of GADOXETATE DISODIUM active pharmaceutical ingredient (API) in detail. Different forms of GADOXETATE DISODIUM DMFs exist exist since differing nations have different regulations, such as GADOXETATE DISODIUM USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A GADOXETATE DISODIUM DMF submitted to regulatory agencies in the US is known as a USDMF. GADOXETATE DISODIUM USDMF includes data on GADOXETATE DISODIUM's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GADOXETATE DISODIUM USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of GADOXETATE DISODIUM suppliers with USDMF on PharmaCompass.
A GADOXETATE DISODIUM written confirmation (GADOXETATE DISODIUM WC) is an official document issued by a regulatory agency to a GADOXETATE DISODIUM manufacturer, verifying that the manufacturing facility of a GADOXETATE DISODIUM active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting GADOXETATE DISODIUM APIs or GADOXETATE DISODIUM finished pharmaceutical products to another nation, regulatory agencies frequently require a GADOXETATE DISODIUM WC (written confirmation) as part of the regulatory process.
click here to find a list of GADOXETATE DISODIUM 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 GADOXETATE DISODIUM as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for GADOXETATE DISODIUM 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 GADOXETATE DISODIUM 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 GADOXETATE DISODIUM and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a GADOXETATE DISODIUM NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of GADOXETATE DISODIUM suppliers with NDC on PharmaCompass.
GADOXETATE DISODIUM 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 GADOXETATE DISODIUM GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right GADOXETATE DISODIUM GMP manufacturer or GADOXETATE DISODIUM GMP API supplier for your needs.
A GADOXETATE DISODIUM CoA (Certificate of Analysis) is a formal document that attests to GADOXETATE DISODIUM's compliance with GADOXETATE DISODIUM specifications and serves as a tool for batch-level quality control.
GADOXETATE DISODIUM CoA mostly includes findings from lab analyses of a specific batch. For each GADOXETATE DISODIUM 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.
GADOXETATE DISODIUM may be tested according to a variety of international standards, such as European Pharmacopoeia (GADOXETATE DISODIUM EP), GADOXETATE DISODIUM JP (Japanese Pharmacopeia) and the US Pharmacopoeia (GADOXETATE DISODIUM USP).
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