Axplora- The partner of choice for complex APIs.
01 2Axplora
02 2TAPI Technology & API Services
03 2SIMS Srl
04 1Blank
01 2FLUNISOLIDE
02 1FLUNISOLIDE ANHYDROUS
03 1FLUNISOLIDE ANHYDROUS (NEW PROCESS)
04 1FLUNISOLIDE ANHYDROUS USP
05 1FLUNISOLIDE HEMIHYDRATE
06 1FLUNISOLIDE HEMIHYDRATE (MICRONIZED)
01 2Germany
02 2Israel
03 2Italy
04 1Blank
01 4Active
02 3Inactive
01 4Complete
02 3Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 19477
Submission : 2006-05-31
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2013-04-10
DMF Number : 11574
Submission : 1995-07-07
Status : Active
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2014-05-27
DMF Number : 26148
Submission : 2012-06-12
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2012-11-08
DMF Number : 22772
Submission : 2009-05-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4774
Submission : 1982-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6811
Submission : 1987-01-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8459
Submission : 1990-02-27
Status : Inactive
Type : II
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