ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Concord Biotech
03 1Hubei Honch Pharmaceutical
04 1Kyowa Hakko Bio
05 1Teva API
06 1Wuxi Fortune Pharmaceutical Co., Ltd
07 2Zhejiang Hisun Pharmaceutical
08 1Blank
01 5MITOMYCIN
02 2MITOMYCIN USP
03 1MITOMYCIN USP (ALTERNATIVE PROCESS)
04 1MITOMYCIN-C CONJUGATED MURINE MONOCLONAL ANTIBODIES
01 4China
02 1India
03 1Israel
04 1Japan
05 1U.S.A
06 1Blank
01 6Active
02 3Inactive
01 4Complete
02 5Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 33811
Submission : 2019-11-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-21
Pay. Date : 2019-04-24
DMF Number : 33662
Submission : 2019-04-20
Status : Active
Type : II
GDUFA
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DMF Number : 37462
Submission : 2023-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 13521
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-09
DMF Number : 13791
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-23
Pay. Date : 2020-09-25
DMF Number : 34866
Submission : 2020-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-08
Pay. Date : 2012-11-15
DMF Number : 25659
Submission : 2011-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13783
Submission : 1998-09-01
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18599
Submission : 1988-07-14
Status : Inactive
Type : II
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