ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1ChemCon GmbH
03 1Emcure Pharmaceuticals
04 1Heraeus Holding
05 1TTY BIOPHARM CO LTD
06 1Umicore
07 1Zydus Lifesciences
01 3Germany
02 2India
03 1Taiwan
04 1U.S.A
01 5Active
02 2Inactive
01 7Blank
01 1224MF10077
02 6Blank
01 7Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-06
Pay. Date : 2014-04-07
DMF Number : 26075
Submission : 2012-05-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-23
Pay. Date : 2017-01-20
DMF Number : 31325
Submission : 2017-01-31
Status : Active
Type : II
NDC Package Code : 72659-245
Start Marketing Date : 2018-01-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33453
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-12
Pay. Date : 2019-06-14
DMF Number : 33758
Submission : 2019-06-07
Status : Active
Type : II
NDC Package Code : 64757-0001
Start Marketing Date : 2014-11-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20033
Submission : 2006-12-13
Status : Active
Type : II
Registration Number : 224MF10077
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2012-04-08
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21092
Submission : 2007-12-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27382
Submission : 2013-09-23
Status : Inactive
Type : II
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