Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1TAPI Technology & API Services
03 1Astellas Pharma
04 1Biocon
05 1BrightGene Bio-Medical Technology Co.,Ltd
06 2Hansoh Pharma
07 1Hetero Drugs
08 1MSN Laboratories
09 1Shanghai Techwell Biopharma.Co., Ltd.
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
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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 : 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 : 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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