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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PharmaCompass offers a list of Gadobutrol 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 Gadobutrol manufacturer or Gadobutrol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadobutrol manufacturer or Gadobutrol supplier.
PharmaCompass also assists you with knowing the Gadobutrol API Price utilized in the formulation of products. Gadobutrol API Price is not always fixed or binding as the Gadobutrol Price is obtained through a variety of data sources. The Gadobutrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gadovist manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadovist, including repackagers and relabelers. The FDA regulates Gadovist manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadovist 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 Gadovist manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadovist supplier is an individual or a company that provides Gadovist active pharmaceutical ingredient (API) or Gadovist finished formulations upon request. The Gadovist suppliers may include Gadovist API manufacturers, exporters, distributors and traders.
click here to find a list of Gadovist suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadovist DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadovist active pharmaceutical ingredient (API) in detail. Different forms of Gadovist DMFs exist exist since differing nations have different regulations, such as Gadovist USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadovist DMF submitted to regulatory agencies in the US is known as a USDMF. Gadovist USDMF includes data on Gadovist's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadovist USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadovist suppliers with USDMF on PharmaCompass.
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