EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Ami Lifesciences Private Limited
03 1Apothecon Pharmaceuticals
04 1Aurobindo Pharma Limited
05 1CHEMO IBERICA SA
06 1CTX Lifesciences
07 1Derivados Quimicos SAU
08 2Emcure Pharmaceuticals
09 1Formosa Laboratories
10 1Hetero Drugs
11 1Lupin Ltd
12 1Solara Active Pharma Sciences
13 1Sun Pharmaceutical Industries Limited
14 1The Dow Chemical Company
15 1Viatris
01 14SEVELAMER HYDROCHLORIDE
02 1SEVELAMER HYDROCHLORIDE (PROCESS II)
03 1SEVELAMER HYDROCHLORIDE (PROCESS-I)
01 1France
02 10India
03 2Spain
04 1Taiwan
05 2U.S.A
01 10Active
02 6Inactive
01 6Complete
02 10Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-09-18
DMF Number : 38198
Submission : 2023-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38016
Submission : 2023-03-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-11
Pay. Date : 2014-03-24
DMF Number : 27908
Submission : 2014-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-30
Pay. Date : 2016-10-28
DMF Number : 31093
Submission : 2016-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22069
Submission : 2008-10-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24872
Submission : 2011-04-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-08-29
DMF Number : 22631
Submission : 2009-03-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2019-02-07
DMF Number : 21488
Submission : 2008-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-25
DMF Number : 21104
Submission : 2007-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25434
Submission : 2011-12-31
Status : Active
Type : II
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