01 1ALP Pharm
02 4BrightGene Bio-Medical Technology Co.,Ltd
03 1Curia
04 1Emcure Pharmaceuticals
05 2GLAND PHARMA LIMITED
06 1Guangzhou Tosun Pharmaceutical
07 1H. Lundbeck AS
08 1Hameln rds
09 1Jiangsu Lianhuan Pharmaceutical
10 1KIVIPharm
11 2KOLON Life Science, Inc
12 1Lunan Pharmaceutical
13 1Mitsubishi Tanabe Pharma
14 1Sailong Pharmaceutical
15 1ScinoPharm Taiwan, Ltd
16 1Sms Lifesciences
17 1Tianjin Weijie Pharmaceutical Co., Ltd.
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06 2South Korea
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03 1302MF10033
04 1303MF10076
05 1304MF10018
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-18
Pay. Date : 2013-10-25
DMF Number : 20760
Submission : 2007-08-07
Status : Active
Type : II
NDC Package Code : 55486-1582
Start Marketing Date : 2012-06-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-01
Pay. Date : 2021-04-14
DMF Number : 35491
Submission : 2020-12-26
Status : Active
Type : II
Registration Number : 305MF10140
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2023-12-22
Latest Date of Registration : --
NDC Package Code : 62227-015
Start Marketing Date : 2018-01-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 25893
Submission : 2012-02-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 25765
Submission : 2012-03-19
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-851
Start Marketing Date : 2023-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 21304
Submission : 2008-01-30
Status : Active
Type : II
NDC Package Code : 45562-1124
Start Marketing Date : 2005-12-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 31131
Submission : 2016-12-05
Status : Active
Type : II
NDC Package Code : 17223-0003
Start Marketing Date : 2014-07-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-12
Pay. Date : 2013-03-26
DMF Number : 25400
Submission : 2011-10-27
Status : Active
Type : II
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-15
Pay. Date : 2014-11-28
DMF Number : 28030
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 7801
Submission : 1988-12-08
Status : Inactive
Type : II
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2022-01-21
Registration Number : 20220121-210-J-1219
Manufacturer Name : Mitsubishi Tanabe Pharma Factory Ltd., Onoda Plant
Manufacturer Address : 7473-2, Ooaza Onoda, SanyoOnoda,Yamaguchi, 756-0054, Japan
GDUFA
DMF Review : N/A
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DMF Number : 22935
Submission : 2009-07-10
Status : Inactive
Type : II
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