Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Cohance Lifesciences
03 1Medichem S.A
04 1Alembic Pharmaceuticals Limited
05 1Alkaloida Chemical Company Zrt
06 1Hetero Drugs
07 1Kalintis Healthcare
08 2Macleods Pharmaceuticals Limited
01 4MEXILETINE HYDROCHLORIDE
02 4MEXILETINE HYDROCHLORIDE USP
03 1MEXILETINE HYDROCHLORIDE USP BULK
01 1Hungary
02 7India
03 1Spain
01 7Active
02 2Inactive
01 7Complete
02 2Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-01
Pay. Date : 2020-08-06
DMF Number : 34668
Submission : 2020-03-06
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-12
Pay. Date : 2021-03-24
DMF Number : 34958
Submission : 2020-06-19
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-21
Pay. Date : 2019-05-23
DMF Number : 9257
Submission : 1991-07-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-02-21
DMF Number : 24714
Submission : 2011-03-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10376
Submission : 1993-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-19
Pay. Date : 2021-06-02
DMF Number : 35983
Submission : 2021-06-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 35146
Submission : 2020-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-09
Pay. Date : 2022-02-24
DMF Number : 36097
Submission : 2021-10-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14442
Submission : 1999-10-07
Status : Inactive
Type : II
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