01 1Apotex Pharmachem
02 1Corden Pharma Bergamo S.p.A
03 1DEAFARMA
04 2EURAND
05 1Eastman Chemical Company
06 3GSK
07 2Gedeon Richter
08 1Grand Health Industrial Co Ltd
09 1Hengdian Group
10 2Jiangsu Baozong & Baoda Pharmachem Co Lt
11 1Jiangsu Zenji Pharmaceuticals,Ltd.
12 1Lek Pharmaceuticals
13 1Quimica Sintetica
14 1Shandong Yangcheng Biotechnology Co. - Ltd
15 1Sms Lifesciences
16 1UNILEVER CANADA INC.
17 1UQUIFA
18 1Wuxi Kaili Pharmaceutical
19 1Yashiro Pharmaceutical Co Ltd
20 11Blank
01 2Canada
02 7China
03 2Hungary
04 1India
05 2Italy
06 1Slovenia
07 2Spain
08 3U.S.A
09 3United Kingdom
10 12Blank
01 2Active
02 20Inactive
03 13Blank
01 2Expired
02 2Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 30Blank
01 1217MF10539
02 1217MF10540
03 1218MF10246
04 1218MF10648
05 1219MF10381
06 1223MF10175
07 1228MF10077
08 1229MF10111
09 27Blank
01 35Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-15
Pay. Date : 2021-07-12
DMF Number : 10982
Submission : 1994-07-11
Status : Active
Type : II
Certificate Number : R1-CEP 1998-023 - Rev 06
Issue Date : 2019-09-03
Type : Chemical
Substance Number : 756
Status : Valid
NDC Package Code : 49711-0095
Start Marketing Date : 2009-10-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Pavis Pharmaceutical Co., Ltd.
Registration Date : 2020-07-17
Registration Number : 20060302-27-B-229-04(14)
Manufacturer Name : Union quimico farmaceutica, SA
Manufacturer Address : Poligon Industrial Moli de Planes Font de Bocs S/N C-35, Km. 5708470 Sant Celoni. Barcelona, Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7234
Submission : 1987-11-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 7863
Submission : 1988-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 12361
Submission : 1997-01-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9637
Submission : 1992-04-09
Status : Inactive
Type : II
Certificate Number : R0-CEP 2000-153 - Rev 01
Issue Date : 2004-11-09
Type : Chemical
Substance Number : 756
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 7201
Submission : 1987-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 8417
Submission : 1990-01-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 12263
Submission : 1996-09-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-008 - Rev 01
Issue Date : 2010-04-27
Type : Chemical
Substance Number : 756
Status : Withdrawn by EDQM F...
Registration Number : 217MF10539
Registrant's Address : Zhoutie Town, Yixing City, Jiangsu Province, P. R. of China
Initial Date of Registration : 2005-09-09
Latest Date of Registration : --
Registrant Name : Yuhan Medica Co., Ltd.
Registration Date : 2012-10-11
Registration Number : 20050831-27-B-63-01(15)
Manufacturer Name : Wuxi Kaili Pharmaceutical Co., Ltd
Manufacturer Address : Zhoutie Town, Yixing City, Jiangsu Province, PR China
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 2716
Submission : 1976-08-10
Status : Inactive
Type : II
Registrant Name : GlaxoSmithKline Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-27-B-66-03
Manufacturer Name : Glaxo SmithKline Ltd
Manufacturer Address : Currabinny, Carrigaline, Co Cork, Ireland
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 5123
Submission : 1983-09-30
Status : Inactive
Type : II
Registrant Name : GlaxoSmithKline Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-27-B-66-03
Manufacturer Name : Glaxo SmithKline Ltd
Manufacturer Address : Currabinny, Carrigaline, Co Cork, Ireland
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