Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1ALP Pharm
03 1Cipla
04 1Eriochem S.A.
05 1Exopharm
06 1Guangzhou Hanfang Pharma. Co. Ltd
07 2Hansoh Pharma
08 1Hubei Honch Pharmaceutical
09 2Pierre Fabre
10 1Qilu Pharmaceutical
11 2Synbias Pharma Limited Liability Company
12 1Zhejiang Hisun Pharmaceutical
13 1Blank
01 1NAVELBINE FOR INJECTION
02 1VINORELBINE DITARTRATE
03 6VINORELBINE TARTRATE
04 1VINORELBINE TARTRATE (NON-STERILE BULK DRUG SUBSTANCE)
05 1VINORELBINE TARTRATE (PROCESS I) (NON STERILE, API)
06 3VINORELBINE TARTRATE USP
07 3VINORELBINE TARTRATE, USP
01 1Argentina
02 1Australia
03 7China
04 3France
05 1India
06 2Ukraine
07 1Blank
01 4Active
02 12Inactive
01 3Complete
02 13Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-23
Pay. Date : 2016-03-23
DMF Number : 14619
Submission : 1999-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16706
Submission : 2003-07-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19094
Submission : 2006-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-10
Pay. Date : 2017-03-14
DMF Number : 31480
Submission : 2017-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16011
Submission : 2002-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-02
Pay. Date : 2015-06-11
DMF Number : 26091
Submission : 2013-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9477
Submission : 1991-11-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9973
Submission : 1992-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15956
Submission : 2002-04-25
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8097
Submission : 1989-06-08
Status : Inactive
Type : II
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