Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Bayer AG
03 1Beijing Beilu Pharma
04 1Formosa Laboratories
05 1Hainan Poly Pharm
06 1Jiangsu Hengrui Medicine
07 1MSN Laboratories
08 1ST Pharma
09 1Sichuan Renan Pharmaceutical
10 1Viwit Pharmaceuticals Limited
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
A Gadobutrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadobutrol, including repackagers and relabelers. The FDA regulates Gadobutrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadobutrol 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 Gadobutrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadobutrol supplier is an individual or a company that provides Gadobutrol active pharmaceutical ingredient (API) or Gadobutrol finished formulations upon request. The Gadobutrol suppliers may include Gadobutrol API manufacturers, exporters, distributors and traders.
click here to find a list of Gadobutrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadobutrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadobutrol active pharmaceutical ingredient (API) in detail. Different forms of Gadobutrol DMFs exist exist since differing nations have different regulations, such as Gadobutrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadobutrol DMF submitted to regulatory agencies in the US is known as a USDMF. Gadobutrol USDMF includes data on Gadobutrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadobutrol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadobutrol suppliers with USDMF on PharmaCompass.
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