Aspen API. More than just an API.
01 1Aspen API
02 1Apicore LLC
03 1Auro Peptides Limited
04 1BCN Peptides
05 1Chengdu Shengnuo Biopharm
06 1Hybio Pharmaceutical
07 1Sun Pharmaceutical Industries Limited
08 1Blank
01 1GANIRELIX
02 6GANIRELIX ACETATE
03 1GANIRELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE
01 2China
02 3India
03 1Netherlands
04 1Spain
05 1Blank
01 8Active
01 5Complete
02 3Blank
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-07
Pay. Date : 2024-03-05
DMF Number : 13971
Submission : 1999-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36902
Submission : 2022-04-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-30
Pay. Date : 2021-07-13
DMF Number : 36108
Submission : 2021-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-04
Pay. Date : 2015-09-18
DMF Number : 29585
Submission : 2015-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-07
Pay. Date : 2020-04-15
DMF Number : 33546
Submission : 2019-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-07-27
DMF Number : 30800
Submission : 2016-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25866
Submission : 2012-03-28
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39994
Submission : 2024-05-29
Status : Active
Type : II
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