01 1Brenntag
02 1CFL Chemische Fabrik Lehrte
03 2Macco Organiques, Spol. s.r o
04 1Manac Incorporated
05 1Merck Group
06 1Nandu Chemicals
07 1Nitika Pharmaceutical Specialities
08 1Tomita Pharmaceutical
09 1Valaji PharmaChem
01 2Czech Republic
02 2Germany
03 3India
04 2Japan
05 1Switzerland
01 3Active
02 7Blank
01 3Valid
02 7Blank
01 1217MF10674
02 1223MF10150
03 1230MF10112
04 1305MF10009
05 6Blank
01 10Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-10
Pay. Date : 2015-05-05
DMF Number : 17834
Submission : 2004-11-16
Status : Active
Type : II
Certificate Number : CEP 2010-194 - Rev 02
Issue Date : 2024-04-30
Type : Chemical
Substance Number : 402
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25841
Submission : 2011-11-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-05
Pay. Date : 2019-01-30
DMF Number : 20488
Submission : 2007-04-26
Status : Active
Type : II
Certificate Number : R1-CEP 2006-264 - Rev 02
Issue Date : 2020-01-02
Type : Chemical
Substance Number : 402
Status : Valid
Registration Number : 305MF10009
Registrant's Address : Zahradni(') 46c,792 01 Brunta(')l, Czech Republic
Initial Date of Registration : 2023-01-18
Latest Date of Registration : --
Registration Number : 223MF10150
Registrant's Address : Zahradni(\') 46c,792 01 Brunta(\')l, Czech Republic
Initial Date of Registration : 2011-10-14
Latest Date of Registration : --
Certificate Number : R1-CEP 2017-044 - Rev 00
Issue Date : 2023-01-25
Type : Chemical
Substance Number : 402
Status : Valid
Registration Number : 230MF10112
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2018-08-20
Latest Date of Registration : --
Registration Number : 217MF10674
Registrant's Address : 92 Minookicho, Fukuyama City, Hiroshima Prefecture
Initial Date of Registration : 2005-10-07
Latest Date of Registration : --
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