ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Inke S.A
03 1Agno Pharma
04 1Apotex Pharmachem
05 1Centaur Pharmaceuticals
06 1CordenPharma
07 1F. Hoffmann-La Roche
08 1H. Lundbeck AS
09 1Hetero Drugs
10 1MSN Laboratories
11 1Piramal Pharma Solutions
12 1Rolabo Outsourcing
13 1Sun Pharmaceutical Industries Limited
14 2Viatris
01 1NITOMAN (TETRABENAZINE) TABLETS
02 1NITOMAN(TETRABENAZINE) TABLETS
03 1TERABENAZINE
04 11TETRABENAZINE
05 1TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE)
01 1Canada
02 1Denmark
03 1Germany
04 4India
05 2Spain
06 1Switzerland
07 5U.S.A
01 13Active
02 2Inactive
01 8Complete
02 7Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24946
Submission : 2011-10-18
Status : Active
Type : II
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37218
Submission : 2022-06-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-19
Pay. Date : 2013-05-24
DMF Number : 27135
Submission : 2013-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-16
Pay. Date : 2014-12-04
DMF Number : 26308
Submission : 2012-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16683
Submission : 2003-07-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-16
Pay. Date : 2013-05-23
DMF Number : 26113
Submission : 2012-06-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-06
Pay. Date : 2015-10-06
DMF Number : 29828
Submission : 2015-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-01
Pay. Date : 2013-06-25
DMF Number : 27186
Submission : 2013-08-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-01
Pay. Date : 2013-06-19
DMF Number : 27147
Submission : 2013-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2014-06-12
DMF Number : 28194
Submission : 2014-06-15
Status : Active
Type : II
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