01 1ACE Japan Co Ltd
02 1Archimica
03 1BK Giulini GmbH
04 1Chugai Pharmaceutical
05 1GSK
06 2Glenmark Life Sciences
07 1MSN Laboratories
08 1Nanjing Pharmaceutical Factory
09 1Nippon Kayaku
10 1Nissei Corporation
11 1Northeast Pharmaceutical Group Co Ltd
12 1ORGAMOL PHARMA SOLUTIONS SA
13 1SNJ Labs
14 1THINQ Pharma-CRO PVT Ltd
15 1Unichem Laboratories Limited
16 1Zhejiang Haisen Pharmaceutical Co., Ltd.
17 2Blank
01 1FACILITIES, PRODUCTION AND CONTROLS FOR
02 10SUCRALFATE
03 1SUCRALFATE (SUCROSE SULFATE ALUMINUM SALT)
04 1SUCRALFATE NON STERILE BULK DRUG SUBSTANCE
05 1SUCRALFATE POWDER
06 4SUCRALFATE USP
07 1SUCRALFATE USP (PROCESS-II)
01 3China
02 1Germany
03 6India
04 1Italy
05 4Japan
06 1Switzerland
07 1United Kingdom
08 2Blank
01 9Active
02 10Inactive
01 5Complete
02 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6108
Submission : 1985-10-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-18
Pay. Date : 2014-04-09
DMF Number : 16589
Submission : 2003-05-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3542
Submission : 1979-06-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-18
Pay. Date : 2022-09-28
DMF Number : 37502
Submission : 2022-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-08
Pay. Date : 2019-01-24
DMF Number : 33479
Submission : 2019-01-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38152
Submission : 2023-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5825
Submission : 1985-05-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38867
Submission : 2023-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-05
Pay. Date : 2024-07-03
DMF Number : 40145
Submission : 2024-07-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-05
Pay. Date : 2015-12-18
DMF Number : 30056
Submission : 2016-02-03
Status : Active
Type : II
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