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 1BrightGene Bio-Medical Technology Co.,Ltd
05 2Hansoh Pharma
06 1Hetero Drugs
07 1MSN Laboratories
08 1Shanghai Techwell Biopharma.Co., Ltd.
09 1TAPI Technology & API Services
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 USP
01 6China
02 3India
03 1Israel
04 1Japan
05 1Spain
01 11Active
02 1Inactive
01 10Complete
02 2Blank
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 : 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 : 2022-02-09
Pay. Date : 2021-12-09
DMF Number : 36296
Submission : 2022-01-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-06
Pay. Date : 2022-10-25
DMF Number : 35657
Submission : 2021-03-30
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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