Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Alembic Pharmaceuticals Limited
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Emcure Pharmaceuticals
06 1Glenmark Life Sciences
07 1Hetero Drugs
08 1Jubilant Generics
09 1Macleods Pharmaceuticals Limited
10 1Natco Pharma
11 1Orchid Pharma
12 1SMS Pharmaceuticals
13 1Sun Pharmaceutical Industries Limited
14 1Suven Life Sciences Limited
15 1Syn-Tech Chem. & Pharm
16 1Teva API
17 1Unichem Laboratories Limited
18 1Viatris
01 13ZOLMITRIPTAN
02 5ZOLMITRIPTAN USP
01 1Canada
02 13India
03 1Israel
04 1Spain
05 1Taiwan
06 1U.S.A
01 16Active
02 2Inactive
01 9Complete
02 9Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-06
Pay. Date : 2019-02-28
DMF Number : 24649
Submission : 2011-02-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-12-20
DMF Number : 22237
Submission : 2008-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23627
Submission : 2010-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24869
Submission : 2011-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21308
Submission : 2008-02-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-04
Pay. Date : 2015-04-21
DMF Number : 20110
Submission : 2007-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25078
Submission : 2011-08-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23207
Submission : 2009-10-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 22205
Submission : 2008-11-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20639
Submission : 2007-06-23
Status : Active
Type : II
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