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 Gadolinium Dtpa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadolinium Dtpa, including repackagers and relabelers. The FDA regulates Gadolinium Dtpa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadolinium Dtpa 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 Gadolinium Dtpa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadolinium Dtpa supplier is an individual or a company that provides Gadolinium Dtpa active pharmaceutical ingredient (API) or Gadolinium Dtpa finished formulations upon request. The Gadolinium Dtpa suppliers may include Gadolinium Dtpa API manufacturers, exporters, distributors and traders.
click here to find a list of Gadolinium Dtpa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadolinium Dtpa DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadolinium Dtpa active pharmaceutical ingredient (API) in detail. Different forms of Gadolinium Dtpa DMFs exist exist since differing nations have different regulations, such as Gadolinium Dtpa USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadolinium Dtpa DMF submitted to regulatory agencies in the US is known as a USDMF. Gadolinium Dtpa USDMF includes data on Gadolinium Dtpa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadolinium Dtpa USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadolinium Dtpa suppliers with USDMF on PharmaCompass.
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