Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Formosa Laboratories
03 1Hainan Poly Pharm
04 1Innopharmax
05 1Jiangsu Hengrui Medicine
06 1Sichuan Renan Pharmaceutical
07 2Viwit Pharmaceuticals Limited
01 7GADOTERATE MEGLUMINE
02 1GADOTERATE MEGLUMINE (DRUG SUBSTANCE)
01 5China
02 1India
03 2Taiwan
01 7Active
02 1Inactive
01 5Complete
02 3Blank
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 : 36148
Submission : 2021-07-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-06
Pay. Date : 2019-09-26
DMF Number : 34129
Submission : 2019-09-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-22
Pay. Date : 2022-06-02
DMF Number : 37072
Submission : 2022-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-30
Pay. Date : 2019-12-17
DMF Number : 34291
Submission : 2019-12-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-29
Pay. Date : 2020-03-13
DMF Number : 34673
Submission : 2020-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39489
Submission : 2024-02-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-28
Pay. Date : 2024-07-25
DMF Number : 38739
Submission : 2023-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34421
Submission : 2020-10-23
Status : Inactive
Type : II
A Gadoterate Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadoterate Meglumine, including repackagers and relabelers. The FDA regulates Gadoterate Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadoterate Meglumine 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 Gadoterate Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadoterate Meglumine supplier is an individual or a company that provides Gadoterate Meglumine active pharmaceutical ingredient (API) or Gadoterate Meglumine finished formulations upon request. The Gadoterate Meglumine suppliers may include Gadoterate Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Gadoterate Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gadoterate Meglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadoterate Meglumine active pharmaceutical ingredient (API) in detail. Different forms of Gadoterate Meglumine DMFs exist exist since differing nations have different regulations, such as Gadoterate Meglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gadoterate Meglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Gadoterate Meglumine USDMF includes data on Gadoterate Meglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadoterate Meglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gadoterate Meglumine suppliers with USDMF on PharmaCompass.
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