Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 1Hubei Gedian Humanwell Pharmaceutical
02 1ChemWerth Inc
03 1Dr. Reddy's Laboratories
04 1TAPI Technology & API Services
05 1ALP Pharm
06 1Aurisco Pharmaceutical
07 1Aurobindo Pharma Limited
08 1Cdymax
09 1Chongqing Pharmaceutical Research Institute Co Ltd
10 2Cipla
11 1Hetero Drugs
12 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
13 2Industriale Chimica
14 3MSN Laboratories
15 1Olon S.p.A
16 1Qilu Antibiotics Pharmaceutical Co., Ltd.
17 1Raks Pharma
18 1ScinoPharm Taiwan, Ltd
19 1Shandong Sito Bio-technology Co ltd
20 2Sterling Spa
21 1Sun Pharmaceutical Industries Limited
22 1Tianjin Weijie Pharmaceutical Co., Ltd.
23 1Zhejiang Shenzhou Pharmaceutical
01 1ABIRATERONE
02 16ABIRATERONE ACETATE
03 1ABIRATERONE ACETATE (NON-STERILE BULK DRUG SUBSTANCE)
04 1ABIRATERONE ACETATE (NON-STERILE)
05 1ABIRATERONE ACETATE API
06 6ABIRATERONE ACETATE USP
07 1ABIRATERONE ACETATE USP (NP)
08 1ABIRATERONE ACETATE USP [ROUTE CODE - "AY"]
01 9China
02 11India
03 1Israel
04 5Italy
05 1Taiwan
06 1U.S.A
01 25Active
02 3Inactive
01 16Complete
02 12Blank
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 : 37965
Submission : 2023-01-16
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-13
Pay. Date : 2014-08-04
DMF Number : 26894
Submission : 2014-07-30
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 : 2014-08-13
Pay. Date : 2014-05-05
DMF Number : 28038
Submission : 2014-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-27
Pay. Date : 2014-10-22
DMF Number : 28764
Submission : 2014-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28292
Submission : 2014-06-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-09
Pay. Date : 2022-06-16
DMF Number : 27853
Submission : 2013-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-12
Pay. Date : 2014-06-27
DMF Number : 27829
Submission : 2013-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-09-06
DMF Number : 27376
Submission : 2013-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-30
Pay. Date : 2014-04-25
DMF Number : 27989
Submission : 2014-02-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-01-10
DMF Number : 26725
Submission : 2012-11-28
Status : Active
Type : II
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