Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Astellas Pharma
03 1Biocon
04 3BrightGene Bio-Medical Technology Co.,Ltd
05 2Hansoh Pharma
06 1Hetero Drugs
07 1MSN Laboratories
08 1Shanghai Techwell Biopharma.Co., Ltd.
09 1Teva API
10 1Yung Shin Pharmaceutical Industrial
11 1Zhejiang Hisun Pharmaceutical
01 1FK463 DRUG SUBSTANCE
02 8MICAFUNGIN SODIUM
03 1MICAFUNGIN SODIUM "YUNG SHIN"
04 1MICAFUNGIN SODIUM (NON-STERILE, API)
05 1MICAFUNGIN SODIUM INTERMEDIATE MCB
06 1MICAFUNGIN SODIUM INTERMEDIATE MFA
07 1MICAFUNGIN SODIUM USP
01 8China
02 3India
03 1Israel
04 1Japan
05 1Spain
01 13Active
02 1Inactive
01 10Complete
02 4Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-20
Pay. Date : 2016-06-02
DMF Number : 30558
Submission : 2016-06-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12856
Submission : 1998-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-09-23
DMF Number : 30880
Submission : 2016-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-03
Pay. Date : 2017-04-06
DMF Number : 31449
Submission : 2017-03-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30028
Submission : 2015-11-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33892
Submission : 2019-06-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-06
Pay. Date : 2018-11-23
DMF Number : 33343
Submission : 2018-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-29
Pay. Date : 2018-05-14
DMF Number : 32812
Submission : 2018-06-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-01
Pay. Date : 2020-08-07
DMF Number : 34888
Submission : 2020-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-23
Pay. Date : 2013-09-13
DMF Number : 27435
Submission : 2013-09-25
Status : Active
Type : II
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