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