Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Bayer AG
03 1Beijing Beilu Pharma
04 1Formosa Laboratories
05 1Hainan Poly Pharm
06 1Jiangsu Hengrui Medicine
07 1MSN Laboratories
08 1ST Pharma
09 1Sichuan Renan Pharmaceutical
10 1Viwit Pharmaceuticals Limited
01 4GADOBUTROL
02 3GADOBUTROL MONOHYDRATE
03 1GADOBUTROL MONOHYDRATE USP
04 2GADOBUTROL USP
01 5China
02 1Germany
03 2India
04 1South Korea
05 1Taiwan
01 10Active
01 6Complete
02 4Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 33420
Submission : 2019-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 13061
Submission : 1998-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 40533
Submission : 2024-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36660
Submission : 2021-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-13
DMF Number : 39149
Submission : 2023-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-19
Pay. Date : 2020-04-29
DMF Number : 34832
Submission : 2020-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-25
Pay. Date : 2023-08-29
DMF Number : 36996
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 38579
Submission : 2023-08-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-30
Pay. Date : 2021-02-26
DMF Number : 35662
Submission : 2021-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-09
Pay. Date : 2024-07-25
DMF Number : 39094
Submission : 2023-11-24
Status : Active
Type : II
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