Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Pharmathen SA
03 2Glenmark Life Sciences
04 1Hetero Drugs
05 1Jubilant Generics
06 3MSN Laboratories
07 1Olon S.p.A
08 1Piramal Pharma Solutions
09 1Shandong Anxin Pharmaceutical
10 1Solara Active Pharma Sciences
11 3Viwit Pharmaceuticals Limited
12 1Wisdom Pharmaceutical
01 9APREPITANT
02 1APREPITANT (DRUG SUBSTANCE, NON-STERILE)
03 1APREPITANT (NON-STERILE API)
04 2APREPITANT USP
05 1APREPITANT USP (BO74 PROCESS)
06 1APREPITANT USP (FORM-I) [ROUTE CODE "FA"]
07 1APREPITANT USP (FORM-II) [ROUTE CODE - "AP2"]
08 1APREPITANT USP (ROUTE CODE - AP)
01 5China
02 1Greece
03 8India
04 1Italy
05 1Spain
06 1U.S.A
01 15Active
02 2Inactive
01 9Complete
02 8Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-31
Pay. Date : 2022-05-16
DMF Number : 35497
Submission : 2022-04-26
Status : Active
Type : II
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-20
Pay. Date : 2017-11-15
DMF Number : 32203
Submission : 2017-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20381
Submission : 2007-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-23
Pay. Date : 2014-01-14
DMF Number : 27610
Submission : 2014-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-10-01
DMF Number : 25572
Submission : 2011-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26852
Submission : 2013-03-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-29
DMF Number : 27214
Submission : 2013-06-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-15
Pay. Date : 2019-07-10
DMF Number : 24835
Submission : 2011-04-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2013-12-12
DMF Number : 27784
Submission : 2013-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26065
Submission : 2012-05-11
Status : Active
Type : II
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