01 1Actylis
02 2Amcol
03 1Beijing Fukangren Biopharmaceutical
04 1Biotechnica DWC
05 1Dolder AG
06 1Fujian South Pharmaceutical
07 1Hosho Co
08 1IMCD Group
09 1Medilux Laboratories
10 1NANTONG HAIERS PHARMACEUTICAL CO., LTD. CN 226400 Rudong
11 1Nantong Chem-land
12 1Nantong Jinghua Pharmaceutical
13 1R-Pharm Germany GmbH
14 1Sailong Pharmaceutical
15 1Sicor de Mexico
16 1Tecoland Corporation
17 1Teikoku Seiyaku Co., Ltd.
18 1Teva API
19 1Teva Pharmaceutical Industries
20 1Welding GmbH & Co.KG
21 8Blank
01 1Algeria
02 6China
03 2Germany
04 1India
05 2Israel
06 2Japan
07 1Mexico
08 1Netherlands
09 1Switzerland
10 4U.S.A
11 8Blank
01 5Active
02 9Inactive
03 15Blank
01 3Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 25Blank
01 1218MF10560
02 1227MF10172
03 27Blank
01 29Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-05-06
Pay. Date : 2020-04-29
DMF Number : 18478
Submission : 2005-06-28
Status : Active
Type : II
Certificate Number : R1-CEP 2000-033 - Rev 07
Issue Date : 2022-05-13
Type : Chemical
Substance Number : 611
Status : Valid
NDC Package Code : 59348-0055
Start Marketing Date : 1982-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12738
Submission : 1997-11-11
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-07
Pay. Date : 2015-07-08
DMF Number : 29443
Submission : 2015-11-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 3062
Submission : 1977-11-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-16
Pay. Date : 2014-05-20
DMF Number : 21774
Submission : 2008-06-30
Status : Active
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 : 1138
Submission : 1968-02-02
Status : Inactive
Type : II
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Website
Corporate PDF
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 : 2892
Submission : 1977-03-08
Status : Inactive
Type : II
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Website
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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 : 6098
Submission : 1985-10-23
Status : Inactive
Type : II
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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 : 7179
Submission : 1987-10-08
Status : Inactive
Type : II
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Website
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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 : 7337
Submission : 1988-02-19
Status : Inactive
Type : II
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