Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
01 1ZACH System SA
02 1ChemWerth Inc
03 1Neuland Laboratories
04 1Akums Lifesciences
05 1Alembic Pharmaceuticals Limited
06 1Amino Chemicals
07 1Aurobindo Pharma Limited
08 1Cadila Pharmaceuticals
09 1Cipla
10 1Glenmark Life Sciences
11 1HONOUR LAB LTD
12 1Jubilant Generics
13 1MSN Laboratories
14 1Megafine Pharma (P) Limited
15 1RANBAXY LABORATORIES LIMITED
16 1Raks Pharma
17 1Sun Pharmaceutical Industries Limited
18 1Tai Heng Industry Co., Ltd
19 1Viatris
20 1Zhejiang Medicine Co Ltd
21 1Zydus Lifesciences
01 3BOSENTAN
02 14BOSENTAN MONOHYDRATE
03 2BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)
04 1BOSENTAN MONOHYDRATE [ROUTE CODE - 'BN']
05 1BOSENTAN, NON-STERILE BULK DRUG SUBSTANCE
01 2China
02 1France
03 15India
04 1Malta
05 2U.S.A
01 19Active
02 2Inactive
01 12Complete
02 9Blank
Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-25
Pay. Date : 2014-01-31
DMF Number : 24929
Submission : 2011-05-09
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2015-03-04
DMF Number : 29001
Submission : 2015-03-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-13
Pay. Date : 2015-07-09
DMF Number : 26038
Submission : 2012-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-06
DMF Number : 25099
Submission : 2011-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23455
Submission : 2010-01-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24124
Submission : 2010-09-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2013-09-26
DMF Number : 25354
Submission : 2011-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-19
Pay. Date : 2013-09-20
DMF Number : 23255
Submission : 2009-11-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-24
Pay. Date : 2012-11-06
DMF Number : 23354
Submission : 2009-12-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-28
Pay. Date : 2014-04-04
DMF Number : 25915
Submission : 2012-04-02
Status : Active
Type : II
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