Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ACS DOBFAR SPA
03 2Aurobindo Pharma Limited
04 1Eli Lilly
05 1Fresenius Kabi AB Brunna
06 1GSK
07 1Nectar Lifesciences
08 1Orchid Pharma
09 2Qilu Antibiotics Pharmaceutical Co., Ltd.
10 1Sterile India Pvt. Ltd
11 1Wockhardt
12 1Zhuhai United Laboratories Co ., Ltd.
01 3CEFUROXIME SODIUM
02 1CEFUROXIME SODIUM (STERILE BULK)
03 2CEFUROXIME SODIUM (STERILE)
04 1CEFUROXIME SODIUM (STERILE) USP
05 1CEFUROXIME SODIUM STERILE
06 1CEFUROXIME SODIUM STERILE USP
07 1CEFUROXIME SODIUM USP
08 1CEFUROXIME SODIUM USP (STERILE)
09 1CEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE
10 1CEFUROXIME SODIUM, STERILE BULK ANTIBIOTIC DRUG SUBSTANCE
11 1STERILE CEFUROXIME SODIUM PROCESS 1, BULK ANTIBIOTIC DRUG SUBSTANCE
01 3China
02 1Germany
03 6India
04 1Italy
05 1Sweden
06 1U.S.A
07 1United Kingdom
01 6Active
02 8Inactive
01 1Complete
02 13Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18722
Submission : 2005-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 13205
Submission : 1998-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18530
Submission : 2005-07-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13675
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15550
Submission : 2001-07-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24411
Submission : 2011-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24627
Submission : 2011-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-09
Pay. Date : 2012-12-20
DMF Number : 26346
Submission : 2012-08-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29983
Submission : 2016-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16649
Submission : 2003-06-16
Status : Inactive
Type : II
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