01 1Ako Kasei
02 1Brenntag
03 1CFL Chemische Fabrik Lehrte
04 1India Phosphate
05 1Macco Organiques Inc
06 1Macco Organiques, Spol. s.r o
07 1Merck Group
08 1Pcca
09 1Tomita Pharmaceutical
10 1Valaji PharmaChem
01 1Canada
02 1Czech Republic
03 2Germany
04 2India
05 2Japan
06 1Switzerland
07 1United Kingdom
01 3Active
02 1Inactive
03 6Blank
01 3Valid
02 7Blank
01 1217MF10519
02 1223MF10151
03 1229MF10097
04 7Blank
01 10Blank
01 10Blank
01 151927-0328
02 167706-0001
03 8Blank
01 10Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34464
Submission : 2020-01-31
Status : Active
Type : IV
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-24
Pay. Date : 2014-03-25
DMF Number : 18502
Submission : 2005-07-01
Status : Active
Type : II
Certificate Number : R1-CEP 2007-356 - Rev 01
Issue Date : 2018-08-28
Type : Chemical
Substance Number : 15
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-23
Pay. Date : 2013-07-02
DMF Number : 14996
Submission : 2000-08-15
Status : Active
Type : II
Certificate Number : R1-CEP 2006-263 - Rev 01
Issue Date : 2016-05-19
Type : Chemical
Substance Number : 15
Status : Valid
Registration Number : 223MF10151
Registrant's Address : Zahradni(') 46c,792 01 Brunta(')l, Czech Republic
Initial Date of Registration : 2011-10-14
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24706
Submission : 2011-02-28
Status : Inactive
Type : II
Registration Number : 217MF10519
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2005-09-07
Latest Date of Registration :
Registration Number : 229MF10097
Registrant's Address : 329 Sakakoshi, Ako City, Hyogo Prefecture
Initial Date of Registration : 2017-05-16
Latest Date of Registration :
NDC Package Code : 67706-0001
Start Marketing Date : 2014-08-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2015-352 - Rev 02
Issue Date : 2025-03-21
Type : Chemical
Substance Number : 15
Status : Valid
NDC Package Code : 51927-0328
Start Marketing Date : 2024-01-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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