01 1Avantor Performance Materials
02 1Eagle Chemical
03 1Global Calcium
04 1Hunan Warrant Chiral Pharmaceutical
05 2Jost Chemical
06 2Macco Organiques, Spol. s.r o
07 1Nitika Pharmaceutical Specialities
08 1PQ Corporation
09 1S D Fine Chem Limited
10 4Tomita Pharmaceutical
11 1Blank
01 1China
02 2Czech Republic
03 4India
04 4Japan
05 4U.S.A
06 1Blank
01 8Active
02 4Inactive
03 4Blank
01 16Blank
01 1217MF10525
02 1227MF10096
03 1227MF10134
04 1228MF10106
05 12Blank
01 16Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2024-04-30
Pay. Date : 2023-12-28
DMF Number : 36873
Submission : 2022-11-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 28690
Submission : 2014-09-29
Status : Active
Type : IV
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-27
Pay. Date : 2018-05-10
DMF Number : 31105
Submission : 2016-11-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 31874
Submission : 2017-09-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-21
Pay. Date : 2013-09-27
DMF Number : 26301
Submission : 2012-08-08
Status : Active
Type : II
Registration Number : 227MF10134
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2015-04-30
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-15
Pay. Date : 2014-07-02
DMF Number : 25133
Submission : 2011-07-05
Status : Active
Type : II
NDC Package Code : 55570-300
Start Marketing Date : 2020-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
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DMF Number : 34100
Submission : 2020-04-17
Status : Active
Type : II
NDC Package Code : 55570-300
Start Marketing Date : 2020-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 25268
Submission : 2011-04-27
Status : Inactive
Type : II
Registration Number : 228MF10106
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2016-06-06
Latest Date of Registration : --
GDUFA
DMF Review : N/A
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DMF Number : 32931
Submission : 2018-10-29
Status : Inactive
Type : II
Registration Number : 227MF10096
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2015-03-20
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 13960
Submission : 1999-01-25
Status : Inactive
Type : II
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