Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Formosa Laboratories
03 1Hainan Poly Pharm
04 1Innopharmax
05 1Jiangsu Hengrui Medicine
06 1Sichuan Renan Pharmaceutical
07 2Viwit Pharmaceuticals Limited
08 1Blank
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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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.
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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.
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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.
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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.
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