Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Hainan Poly Pharm
03 1Sichuan Renan Pharmaceutical
01 2GADOTERIDOL
02 1GADOTERIDOL USP
01 2China
02 1India
01 3Active
01 2Complete
02 1Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-03
Pay. Date : 2020-09-24
DMF Number : 35047
Submission : 2020-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-21
Pay. Date : 2023-02-03
DMF Number : 37960
Submission : 2023-02-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40243
Submission : 2024-07-25
Status : Active
Type : II
A Gadoteridol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadoteridol, including repackagers and relabelers. The FDA regulates Gadoteridol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadoteridol 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 Gadoteridol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadoteridol supplier is an individual or a company that provides Gadoteridol active pharmaceutical ingredient (API) or Gadoteridol finished formulations upon request. The Gadoteridol suppliers may include Gadoteridol API manufacturers, exporters, distributors and traders.
click here to find a list of Gadoteridol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadoteridol DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadoteridol active pharmaceutical ingredient (API) in detail. Different forms of Gadoteridol DMFs exist exist since differing nations have different regulations, such as Gadoteridol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadoteridol DMF submitted to regulatory agencies in the US is known as a USDMF. Gadoteridol USDMF includes data on Gadoteridol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadoteridol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadoteridol suppliers with USDMF on PharmaCompass.
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