Aspen API. More than just an API.
01 1Aspen API
02 1Medichem S.A
03 1Alembic Pharmaceuticals Limited
04 1CHEMO IBERICA SA
05 1Hisamitsu Pharmaceutical Co., Inc.
06 1Lupin Ltd
07 2MSN Laboratories
08 1Megafine Pharma (P) Limited
09 1Olon S.p.A
10 1Sigmapharm Laboratories, LLC
11 1Signa S.A. de C.V.
12 1Sun Pharmaceutical Industries Limited
13 1Viatris
01 7ASENAPINE MALEATE
02 1ASENAPINE MALEATE (MICRONIZED)
03 1ASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE)
04 1ASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX
05 1ASENAPINE MALEATE [ROUTE CODE "AOI"]
06 1ASENAPINE MALEATE [ROUTE CODE AN]
07 1HP-3070 TRANSDERMAL SYSTEM
08 1MED-200056/E
01 6India
02 1Italy
03 1Japan
04 1Mexico
05 1Netherlands
06 2Spain
07 2U.S.A
01 11Active
02 3Inactive
01 8Complete
02 6Blank
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34868
Submission : 2020-06-10
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-05-01
DMF Number : 26923
Submission : 2013-05-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-19
Pay. Date : 2013-08-08
DMF Number : 27194
Submission : 2013-07-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-07-30
DMF Number : 27292
Submission : 2013-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-06-12
DMF Number : 26973
Submission : 2013-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-09
Pay. Date : 2013-05-24
DMF Number : 26785
Submission : 2013-03-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26104
Submission : 2012-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-08-13
DMF Number : 27300
Submission : 2013-08-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-01
Pay. Date : 2013-06-25
DMF Number : 27185
Submission : 2013-07-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-05-13
DMF Number : 27086
Submission : 2013-05-17
Status : Active
Type : II
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