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DOSAGE - INJECTABLE;INJECTION - 469.01MG/ML
USFDA APPLICATION NUMBER - 19596
DOSAGE - INJECTABLE;INJECTION - 469.01MG/ML
USFDA APPLICATION NUMBER - 21037
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ABOUT THIS PAGE
A Gadopentetate Dimeglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadopentetate Dimeglumine, including repackagers and relabelers. The FDA regulates Gadopentetate Dimeglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadopentetate Dimeglumine 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 Gadopentetate Dimeglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadopentetate Dimeglumine supplier is an individual or a company that provides Gadopentetate Dimeglumine active pharmaceutical ingredient (API) or Gadopentetate Dimeglumine finished formulations upon request. The Gadopentetate Dimeglumine suppliers may include Gadopentetate Dimeglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Gadopentetate Dimeglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadopentetate Dimeglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadopentetate Dimeglumine active pharmaceutical ingredient (API) in detail. Different forms of Gadopentetate Dimeglumine DMFs exist exist since differing nations have different regulations, such as Gadopentetate Dimeglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadopentetate Dimeglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Gadopentetate Dimeglumine USDMF includes data on Gadopentetate Dimeglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadopentetate Dimeglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadopentetate Dimeglumine suppliers with USDMF on PharmaCompass.
Gadopentetate Dimeglumine 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 Gadopentetate Dimeglumine 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 Gadopentetate Dimeglumine GMP manufacturer or Gadopentetate Dimeglumine GMP API supplier for your needs.
A Gadopentetate Dimeglumine CoA (Certificate of Analysis) is a formal document that attests to Gadopentetate Dimeglumine's compliance with Gadopentetate Dimeglumine specifications and serves as a tool for batch-level quality control.
Gadopentetate Dimeglumine CoA mostly includes findings from lab analyses of a specific batch. For each Gadopentetate Dimeglumine 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.
Gadopentetate Dimeglumine may be tested according to a variety of international standards, such as European Pharmacopoeia (Gadopentetate Dimeglumine EP), Gadopentetate Dimeglumine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gadopentetate Dimeglumine USP).
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