Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 2Symbiotec Pharmalab
02 1EUROAPI
03 1Aspen API
04 1Hubei Gedian Humanwell Pharmaceutical
05 1Aurisco Pharmaceutical
06 2Bayer AG
07 1DMFs Not Supported
08 3Fujifilm Diosynth Biotechnologies
09 2Henan Lihua Pharmaceutical
10 1Hunan Yuxin Pharmaceutical Co., Ltd.
11 1Laboratorio Syntex S.A
12 1Medimpex
13 1Pfizer Inc
14 1Shandong Xinhua Pharmaceutical
15 1Tianjin Pharmaceutical Holdings Ltd
16 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
17 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 216-ALPHA-HYDROXYPREDNISOLONE
02 116ALPHA-HYDROXY PREDNISOLONE
03 116ALPHA-HYDROXYPREDNISOLONE
04 7PREDNISOLONE
05 1PREDNISOLONE 21-HEMISUCCINATE
06 1PREDNISOLONE ANHYDROUS, USP
07 1PREDNISOLONE HEMI SUCCINATE
08 1PREDNISOLONE MICRO
09 1PREDNISOLONE SUCCINATE
10 1PREDNISOLONE SUCCINATE (PREDNISOLONE HYDROGEN SUCCINATE)
11 1PREDNISOLONE TEBUTATE
12 2PREDNISOLONE USP
13 1PREDNISOLONE USP (PROCESS I)
14 1PREDNISOLONE USP BULK
01 1Argentina
02 9China
03 1France
04 2Germany
05 2India
06 1Netherlands
07 1U.S.A
08 4United Kingdom
09 1Blank
01 11Active
02 11Inactive
01 4Complete
02 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24630
Submission : 2011-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-28
Pay. Date : 2013-01-03
DMF Number : 3535
Submission : 1979-06-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8855
Submission : 1990-11-26
Status : Active
Type : II
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27423
Submission : 2013-08-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-06
Pay. Date : 2021-04-09
DMF Number : 34505
Submission : 2020-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28490
Submission : 2014-08-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30625
Submission : 2016-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27631
Submission : 2013-07-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-04-13
DMF Number : 18716
Submission : 2005-08-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 18063
Submission : 2005-02-08
Status : Active
Type : II
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