Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 2Hubei Gedian Humanwell Pharmaceutical
02 1Dr. Reddy's Laboratories
03 1Aurobindo Pharma Limited
04 2Catalent Pharma Solutions
05 1Cipla
06 1Gador SA
07 1Hetero Drugs
08 1Ind Swift Laboratories Limited
09 2MSN Laboratories
10 1PHF SA
11 1Reliance Life Sciences Private Limited
12 2Sterling Spa
13 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
01 7DUTASTERIDE
02 1DUTASTERIDE (PROCESS-II) USP
03 1DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES
04 1DUTASTERIDE ACID
05 1DUTASTERIDE FORM I
06 1DUTASTERIDE SOFT GELATIN CAPSULES .5MG
07 3DUTASTERIDE USP
08 1DUTASTERIDE USP [ROUTE CODE - "DT"]
09 1DUTASTERIDE, NON-STERILE, BULK DRUG SUBSTANCE
01 1Argentina
02 3China
03 8India
04 2Italy
05 1Switzerland
06 2U.S.A
01 9Active
02 8Inactive
01 6Complete
02 11Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-24
Pay. Date : 2021-04-02
DMF Number : 26803
Submission : 2013-01-09
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-12
Pay. Date : 2012-11-30
DMF Number : 26475
Submission : 2012-10-03
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 : 27763
Submission : 2013-12-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-07-28
DMF Number : 29577
Submission : 2015-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14643
Submission : 1999-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-04
Pay. Date : 2013-12-10
DMF Number : 27774
Submission : 2013-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33063
Submission : 2018-08-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-06
DMF Number : 23533
Submission : 2010-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30143
Submission : 2015-12-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-07
Pay. Date : 2015-04-30
DMF Number : 20918
Submission : 2007-10-08
Status : Active
Type : II
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