Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1ChemWerth Inc
03 1Veranova
04 1ALP Pharm
05 1Hospira, Inc.
06 1MSN Laboratories
07 1Nanjing Pharmaceutical
01 2CLEVIDIPINE
02 3CLEVIDIPINE BUTYRATE
03 1CLEVIDIPINE BUTYRATE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
04 1CLEVIDIPINE EMULSION
01 2China
02 1India
03 1Spain
04 3U.S.A
01 6Active
02 1Inactive
01 3Complete
02 4Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-02
Pay. Date : 2022-03-17
DMF Number : 36436
Submission : 2022-06-14
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 34556
Submission : 2020-06-01
Status : Active
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16771
Submission : 2003-08-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-25
Pay. Date : 2018-05-25
DMF Number : 29850
Submission : 2016-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11365
Submission : 1995-02-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34634
Submission : 2020-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37767
Submission : 2022-12-22
Status : Active
Type : II
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