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
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01 8Active
02 4Inactive
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01 16Blank
01 1217MF10525
02 1227MF10096
03 1227MF10134
04 1228MF10106
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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
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DMF Number : 28690
Submission : 2014-09-29
Status : Active
Type : IV
GDUFA
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DMF Number : 33571
Submission : 2019-03-08
Status : Active
Type : II
NDC Package Code : 10106-5054
Start Marketing Date : 2019-01-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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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
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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
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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
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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
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GDUFA
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DMF Number : 13960
Submission : 1999-01-25
Status : Inactive
Type : II
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DMF Number : 1816
Submission : 1971-10-22
Status : Inactive
Type : II
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