01 1Arcadia Lifescience
02 1F. Hoffmann-La Roche
03 1Hengdian Group
04 1Innova Remedies
05 2Olon S.p.A
06 1Sinbiotik
07 3Sumitomo Chemical
08 1Zhejiang Jiuzhou Pharmaceutical
01 1Canada
02 2China
03 1India
04 2Italy
05 3Japan
06 1Mexico
07 1Switzerland
01 1Active
02 10Blank
01 4Valid
02 7Blank
01 1218MF10019
02 1219MF10226
03 1222MF10051
04 1223MF10164
05 7Blank
01 11Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27497
Submission : 2013-09-03
Status : Active
Type : II
Certificate Number : R1-CEP 2004-107 - Rev 04
Issue Date : 2021-06-15
Type : Chemical
Substance Number : 1394
Status : Valid
Registration Number : 218MF10019
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2006-01-27
Latest Date of Registration : --
NDC Package Code : 17337-0094
Start Marketing Date : 2020-09-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2010-252 - Rev 00
Issue Date : 2016-06-13
Type : Chemical
Substance Number : 1394
Status : Valid
Certificate Number : R1-CEP 1998-124 - Rev 04
Issue Date : 2010-11-26
Type : Chemical
Substance Number : 1394
Status : Valid
Registration Number : 222MF10051
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2010-02-12
Latest Date of Registration : --
Registration Number : 223MF10164
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-11-28
Latest Date of Registration : --
Certificate Number : R1-CEP 2001-149 - Rev 07
Issue Date : 2020-09-18
Type : Chemical
Substance Number : 1394
Status : Valid
NDC Package Code : 17337-0094
Start Marketing Date : 2020-09-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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