Aspen API. More than just an API.
01 1Aspen API
02 1TAPI Technology & API Services
03 1ALP Pharm
04 1AmbioPharm
05 1Chemi SpA
06 1Chengdu Shengnuo Biopharm
07 1CordenPharma
08 1Hainan Shuangcheng Pharmaceuticals
09 1Hybio Pharmaceutical
10 2PolyPeptide Group
11 1Sun Pharmaceutical Industries Limited
12 1Wuxi Kaili Pharmaceutical
13 2Blank
01 11EPTIFIBATIDE
02 1EPTIFIBATIDE (BULK)
03 1EPTIFIBATIDE (NON-STERILE)
04 1EPTIFIBATIDE ACETATE, NON-STERILE BULK DRUG SUBSTANCE
05 1EPTIFIBATIDE DRUG SUBSTANCE
01 5China
02 1Germany
03 1India
04 1Israel
05 1Italy
06 1Netherlands
07 2Switzerland
08 1U.S.A
09 2Blank
01 10Active
02 5Inactive
01 7Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14267
Submission : 1999-07-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 21913
Submission : 2008-08-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2015-08-27
DMF Number : 23786
Submission : 2010-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-29
Pay. Date : 2013-05-06
DMF Number : 24864
Submission : 2011-04-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-01-17
DMF Number : 27651
Submission : 2013-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-09-05
DMF Number : 31837
Submission : 2017-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-01
Pay. Date : 2014-05-07
DMF Number : 26453
Submission : 2012-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18565
Submission : 2005-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-27
Pay. Date : 2013-01-30
DMF Number : 26795
Submission : 2013-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26457
Submission : 2012-09-12
Status : Active
Type : II
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