01 3Chugoku Kayaku
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 2Dipharma
04 1EIRCHEM Pharma Services
05 1IQT Industrias Quimicas Taubate
06 1Industriale Chimica
07 1Jinzhou Jiutai Pharmaceutical
08 1Kremers Urban Pharmaceuticals
09 1Lunan Pharmaceutical
10 1Lusochimica
11 1Mallinckrodt Pharmaceuticals
12 1Muromachi Chemicals Inc
13 2Nitto Denko Avecia
14 1Stuart Therapeutics
15 1Xian Libang Pharmaceutical Co.,Ltd
16 1Zim Laboratories
17 5Blank
01 1Brazil
02 3China
03 1India
04 2Ireland
05 4Italy
06 4Japan
07 1Switzerland
08 4U.S.A
09 5Blank
01 4Active
02 11Inactive
03 10Blank
01 3Valid
02 22Blank
01 1217MF10572
02 1217MF10795
03 1217MF10796
04 1217MF10797
05 1217MF11278
06 20Blank
01 25Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9228
Submission : 1991-07-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2663
Submission : 1976-05-07
Status : Active
Type : II
Registration Number : 217MF11278
Registrant's Address : Hembrunnstr. 17, CH-5605 Dottikon, Switzerland
Initial Date of Registration : 2005-12-20
Latest Date of Registration : --
NDC Package Code : 54864-106
Start Marketing Date : 1983-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20200828-209-J-668(1)
Manufacturer Name : Dottikon Exclusive Synthesis AG
Manufacturer Address : Hembrunnstrasse 17 CH-5605 Dottikon Switzerland
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-12
Pay. Date : 2024-01-31
DMF Number : 36099
Submission : 2021-12-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-15
Pay. Date : 2016-02-25
DMF Number : 3725
Submission : 1980-02-07
Status : Active
Type : II
Certificate Number : R1-CEP 2013-295 - Rev 00
Issue Date : 2022-02-09
Type : Chemical
Substance Number : 1117
Status : Valid
NDC Package Code : 46438-0001
Start Marketing Date : 2005-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Erison Pharmaceutical Co., Ltd.
Registration Date : 2023-01-06
Registration Number : 20220825-209-J-1350(1)
Manufacturer Name : Dipharma Francis Srl
Manufacturer Address : Via XXIV Maggio 40-33036 Mereto di Tomba (UD) Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4403
Submission : 1981-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4172
Submission : 1981-05-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2713
Submission : 1976-07-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 345
Submission : 1959-09-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5460
Submission : 1984-07-18
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1021
Submission : 1967-01-12
Status : Inactive
Type : II
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