Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Vamsi Labs
03 1Seqens
04 2Boehringer Ingelheim GmbH
05 2Cerbios-Pharma SA
06 1Industriale Chimica
07 1Lupin Ltd
08 1TAPI Technology & API Services
01 1TIOTROPIUM BROMIDE MONOHYDRATE
02 3TIOTROPIUM BROMIDE
03 5TIOTROPIUM BROMIDE MONOHYDRATE
04 1TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)
01 1France
02 2Germany
03 2India
04 1Israel
05 1Italy
06 1Spain
07 2Switzerland
01 8Active
02 2Inactive
01 7Complete
02 3Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-30
Pay. Date : 2020-01-13
DMF Number : 34410
Submission : 2020-03-17
Status : Active
Type : II
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-11
Pay. Date : 2020-11-04
DMF Number : 34808
Submission : 2020-04-15
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-16
Pay. Date : 2013-12-31
DMF Number : 28161
Submission : 2013-12-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21939
Submission : 2008-09-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18135
Submission : 2005-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36281
Submission : 2021-10-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-03
Pay. Date : 2015-02-05
DMF Number : 28820
Submission : 2015-01-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-07
Pay. Date : 2023-07-27
DMF Number : 27120
Submission : 2013-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-20
Pay. Date : 2015-11-19
DMF Number : 29726
Submission : 2016-01-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-15
Pay. Date : 2013-09-17
DMF Number : 27524
Submission : 2013-10-23
Status : Active
Type : II
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