Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 2Hubei Gedian Humanwell Pharmaceutical
02 2Pfizer CentreOne
03 1Symbiotec Pharmalab
04 1Aspen API
05 2ACS DOBFAR SPA
06 1Actavis Inc
07 2Catalent Pharma Solutions
08 1F.I.S. Fabbrica Italiana Sintetici
09 1Industriale Chimica
10 1JiangXi Hongyuan Pharmaceutical Material
11 2Jiangsu Jiaerke Pharmaceuticals Group
12 2Laboratorio Syntex S.A
13 1Organon
14 1Productos Quimicos Naturales
15 1Quimica Sintetica
16 1SIGMA TAU
17 1Signa S.A. de C.V.
18 2Zhejiang Shenzhou Pharmaceutical
19 1Zhejiang Xianju Xianming Pharmaceutical
20 2Blank
01 117a - ACETOXY PROGESTERONE
02 117a-HYDROXYPROGESTERONE, BULK
03 16- CHLORO - 6 - DEHYDRO- 17A - ACETOXY PROGESTERONE
04 190 DAY PROGESTERONE
05 1MEDROXY PROGESTERONE ACETATE
06 10PROGESTERONE
07 1PROGESTERONE (PROCESS II)
08 1PROGESTERONE 16a, 17a- ACETOPHENIDE
09 1PROGESTERONE API PROCESS II
10 1PROGESTERONE MICRONIZED AND CRYSTALS
11 1PROGESTERONE SOFT GELATIN CAPSULES 100 MG AND 200 MG
12 4PROGESTERONE USP
13 1PROGESTERONE USP (BULK)
14 1PROGESTERONE VAGINAL SUPPOSITORY 100 MG. AND 200 MG.
15 1PROGESTERONE, USP
16 1PROMETRIUM 100-MG AND 200-MG SOFT-GELATIN CAPSULE
01 2Argentina
02 8China
03 1India
04 1Ireland
05 4Italy
06 2Mexico
07 1Netherlands
08 1Spain
09 6U.S.A
10 2Blank
01 13Active
02 15Inactive
01 11Complete
02 17Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-25
Pay. Date : 2018-07-27
DMF Number : 27668
Submission : 2013-11-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 1418
Submission : 1969-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-11
Pay. Date : 2019-06-10
DMF Number : 32709
Submission : 2018-04-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-14
Pay. Date : 2019-05-09
DMF Number : 3823
Submission : 1980-05-20
Status : Active
Type : II
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-11
Pay. Date : 2021-01-12
DMF Number : 33003
Submission : 2018-07-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-03
Pay. Date : 2018-03-16
DMF Number : 32099
Submission : 2017-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-22
Pay. Date : 2012-12-10
DMF Number : 22096
Submission : 2008-11-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28655
Submission : 2014-09-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-05
Pay. Date : 2019-10-29
DMF Number : 5416
Submission : 1984-06-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-21
Pay. Date : 2015-01-13
DMF Number : 19792
Submission : 2006-09-18
Status : Active
Type : II
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