Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Cipla
03 1GSK
04 1Hikma Pharmaceuticals
05 1Lupin Ltd
06 1Melody Healthcare Pvt Ltd
07 1Olon S.p.A
08 1Sterling Chemical Malta
09 1Teva API
01 9UMECLIDINIUM BROMIDE
01 3India
02 1Israel
03 1Italy
04 1Malta
05 1Spain
06 2United Kingdom
01 9Active
01 3Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-12
Pay. Date : 2023-01-09
DMF Number : 36482
Submission : 2023-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38002
Submission : 2023-03-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26339
Submission : 2012-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35420
Submission : 2021-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38295
Submission : 2023-04-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38379
Submission : 2023-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-30
Pay. Date : 2023-01-13
DMF Number : 37680
Submission : 2023-03-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39843
Submission : 2024-04-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-08
DMF Number : 32945
Submission : 2018-08-12
Status : Active
Type : II
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