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
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A gadolinium-DO3A-butriol DMF (Drug Master File) is a document detailing the whole manufacturing process of gadolinium-DO3A-butriol active pharmaceutical ingredient (API) in detail. Different forms of gadolinium-DO3A-butriol DMFs exist exist since differing nations have different regulations, such as gadolinium-DO3A-butriol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A gadolinium-DO3A-butriol DMF submitted to regulatory agencies in the US is known as a USDMF. gadolinium-DO3A-butriol USDMF includes data on gadolinium-DO3A-butriol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The gadolinium-DO3A-butriol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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