01 1ALCAFTADINE
02 1BEXAROTENE
03 1BORTEZOMIB
04 1BUSULFAN USP
05 1CEVIMELINE HYDROCHLORIDE USP
06 1CYCLOPHOSPHAMIDE USP (STERILE BULK)
07 1DEGARELIX ACETATE MANNITOL PREMIX 29% (STERILE)
08 1DEGARELIX ACETATE MANNITOL PREMIX 45% (STERILE)
09 1FELBAMATE
10 1FERRIC CARBOXYMALTOSE
11 1FERUMOXYTOL
12 1FLIBANSERIN
13 1GANIRELIX ACETATE
14 1INDOCYANINE GREEN, USP
15 1LURBINECTEDIN
16 1METYROSINE, USP
17 1MTB008
18 1PENICILLAMINE, USP
19 1PERPHENAZINE USP
20 1PHENTOLAMINE MESYLATE USP
21 1Protriptyline Hydrochloride
22 1SAFINAMIDE MESYLATE
23 1SELEGILINE
24 1SELEXIPAG-MANNITOL PREMIX
25 1SEMAGLUTIDE
26 1TIRZEPATIDE
27 1TRABECTEDIN
28 1VORICONAZOLE, USP
01 1AKTINOS PHARMA PRIVATE LTD
02 16APICORE LLC
03 2APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)
04 4APICORE PHARMACEUTICALS PRIVATE LTD
05 5APICORE US LLC
01 7India
02 21U.S.A
01 25Active
02 3Inactive
01 11Complete
02 17Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32382
Submission : 2018-01-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-07
Pay. Date : 2015-07-29
DMF Number : 23631
Submission : 2010-04-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-09-20
DMF Number : 22922
Submission : 2009-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-10
Pay. Date : 2015-05-27
DMF Number : 23924
Submission : 2010-08-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-15
Pay. Date : 2021-09-27
DMF Number : 36089
Submission : 2021-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37005
Submission : 2023-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37113
Submission : 2023-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20438
Submission : 2007-04-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36795
Submission : 2022-03-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39032
Submission : 2023-10-24
Status : Active
Type : II
LOOKING FOR A SUPPLIER?
