With Fermion, start the journey of your innovative API.
01 1Fermion Oy
02 2Moehs Iberica
03 1ChemWerth Inc
04 1Alcami
05 1Ascensus Specialties
06 1Asymchem Laboratories
07 1Emcure Pharmaceuticals
08 1Fuan Pharmaceutical
09 2GLAND PHARMA LIMITED
10 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
11 1Interquim Mexico
12 1Jiangsu Hengrui Medicine
13 1Maithri Drugs
14 1Recipharm AB
15 1Reliable Biopharmaceutical Corporation
16 1Blank
01 1DEXMEDETOMIDINE DRUG SUBSTANCE
02 1DEXMEDETOMIDINE HCI
03 2DEXMEDETOMIDINE HCL
04 6DEXMEDETOMIDINE HYDROCHLORIDE
05 5DEXMEDETOMIDINE HYDROCHLORIDE USP
06 1DEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071)
07 1DEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE
08 1DEXMEDETOMIDINE TRANSDERMAL SYSTEM (DEXMED TX) REDWOOD CITY, CA.
01 3China
02 1Finland
03 4India
04 1Mexico
05 2Spain
06 1Sweden
07 5U.S.A
08 1Blank
01 17Active
02 1Inactive
01 12Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-31
Pay. Date : 2021-08-26
DMF Number : 13810
Submission : 1998-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-21
Pay. Date : 2018-12-11
DMF Number : 33404
Submission : 2018-12-03
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 : 2013-03-27
Pay. Date : 2012-12-17
DMF Number : 24202
Submission : 2011-12-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-08
Pay. Date : 2022-01-27
DMF Number : 36478
Submission : 2022-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-24
DMF Number : 22681
Submission : 2009-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2012-12-19
DMF Number : 26223
Submission : 2012-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23232
Submission : 2009-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2013-04-29
DMF Number : 26377
Submission : 2012-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-17
Pay. Date : 2014-04-09
DMF Number : 26984
Submission : 2013-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23132
Submission : 2009-09-28
Status : Active
Type : II
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