Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Alembic Pharmaceuticals Limited
03 1Apicore LLC
04 1Apotex Pharmachem
05 1HONOUR LAB LTD
06 1MSN Laboratories
07 3Maithri Drugs
08 1Zhejiang Huayi Pharmaceutical Co., Ltd.
01 5SELEXIPAG
02 1SELEXIPAG (AMORPHOUS)
03 1SELEXIPAG (FORM-I)
04 1SELEXIPAG (FORM-III)
05 1SELEXIPAG (FORM-P)
06 1SELEXIPAG-MANNITOL PREMIX
01 1Canada
02 1China
03 8India
01 10Active
01 4Complete
02 6Blank
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 : 33947
Submission : 2019-06-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-12
Pay. Date : 2019-07-16
DMF Number : 33974
Submission : 2019-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35163
Submission : 2020-09-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-06
Pay. Date : 2019-05-23
DMF Number : 33828
Submission : 2019-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-01
Pay. Date : 2019-01-28
DMF Number : 33061
Submission : 2018-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-23
Pay. Date : 2019-03-20
DMF Number : 32123
Submission : 2017-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36155
Submission : 2021-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33561
Submission : 2019-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39699
Submission : 2024-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39287
Submission : 2023-12-18
Status : Active
Type : II
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