Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Neuland Laboratories
03 1Alkem Laboratories
04 3Apotex Pharmachem
05 2Aurobindo Pharma Limited
06 1Cadila Pharmaceuticals
07 1Chromo Laboratories
08 2Cipla
09 1HEC Pharm
10 2Hansoh Pharma
11 1Hetero Drugs
12 1Ipca Laboratories
13 2Jubilant Generics
14 1Kyongbo Pharmaceutical Co., Ltd
15 1Lee Pharma
16 1Lek Pharmaceuticals
17 1Macleods Pharmaceuticals Limited
18 1Orchid Pharma
19 1Qilu Pharmaceutical
20 1RANBAXY LABORATORIES LIMITED
21 1Solara Active Pharma Sciences
22 1Sun Pharmaceutical Industries Limited
23 1Teva API
24 1Torrent Pharmaceuticals Limited
25 1Venkat Pharma
26 1Viatris
27 1Zhejiang Hisun Pharmaceutical
28 1Zhejiang Supor Pharmaceuticals Co., LTD
29 2Zydus Lifesciences
01 11OLANZAPINE
02 1OLANZAPINE (FORM-1)
03 1OLANZAPINE (FORM-I)
04 1OLANZAPINE DRUG SUBSTANCE
05 1OLANZAPINE FORM II USP
06 1OLANZAPINE FORM-1 USP
07 1OLANZAPINE FORM-I USP
08 2OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE
09 13OLANZAPINE USP
10 1OLANZAPINE USP (CRYSTALLINE POLYMORPH FORM-II)
11 1OLANZAPINE USP (FORM-I)
12 1OLANZAPINE USP (NON-STERILE DRUG SUBSTANCE)
13 1OLANZAPINE USP, NON-STERILE
01 3Canada
02 6China
03 1Iceland
04 21India
05 1Israel
06 1Slovenia
07 1South Korea
08 1Spain
09 1U.S.A
01 25Active
02 11Inactive
01 15Complete
02 21Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-03
Pay. Date : 2013-01-23
DMF Number : 26694
Submission : 2013-01-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19282
Submission : 2006-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-20
DMF Number : 21980
Submission : 2008-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-13
Pay. Date : 2013-09-11
DMF Number : 22301
Submission : 2008-12-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-12-10
DMF Number : 20591
Submission : 2007-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-12-17
DMF Number : 20990
Submission : 2007-10-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-07-09
DMF Number : 18260
Submission : 2005-04-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21506
Submission : 2008-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-18
Pay. Date : 2014-02-10
DMF Number : 20218
Submission : 2007-01-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22555
Submission : 2009-02-18
Status : Active
Type : II
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