Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Seven Star Pharmaceutical
01 2GADOPENTETATE DIMEGLUMINE
01 1India
02 1Taiwan
01 2Active
01 1Complete
02 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 : 38615
Submission : 2023-07-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-04-04
DMF Number : 26647
Submission : 2012-11-08
Status : Active
Type : II
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.
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