Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Neuland Laboratories
03 1Cipla
04 1GSK
05 1Lupin Ltd
06 1MSN Laboratories
07 1Melody Healthcare Pvt Ltd
08 1Sterling Chemical Malta
01 6VILANTEROL TRIFENATATE
02 1VILANTEROL TRIFENATATE (GW642444)
03 1VILANTEROL TRIFENATATE IH
01 5India
02 1Malta
03 1Spain
04 1United Kingdom
01 8Active
01 1Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-19
Pay. Date : 2023-01-09
DMF Number : 35498
Submission : 2023-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36450
Submission : 2022-01-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39385
Submission : 2024-02-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25906
Submission : 2012-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36668
Submission : 2022-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37700
Submission : 2022-11-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34083
Submission : 2019-10-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39842
Submission : 2024-04-15
Status : Active
Type : II
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