Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1TAPI Technology & API Services
03 2Amoli Organics
04 1Aurobindo Pharma Limited
05 1Azico Biophore India Pvt. Ltd
06 1Cadila Pharmaceuticals
07 1Hetero Drugs
08 1MSN Laboratories
09 1Macleods Pharmaceuticals Limited
10 1Par Pharmaceutical
11 1Raks Pharma
12 2SMS Pharmaceuticals
13 1Sichuan Kelun Pharmaceutical
14 1Signa S.A. de C.V.
15 1Sms Lifesciences
16 1Torrent Pharmaceuticals Limited
17 2Viatris
01 1SILDENAFIL
02 7SILDENAFIL CITRATE
03 1SILDENAFIL CITRATE (NON-STERILE BULK DRUG SUBSTANCE)
04 1SILDENAFIL CITRATE (UNIT-II)
05 1SILDENAFIL CITRATE FORM-II
06 6SILDENAFIL CITRATE USP
07 1SILDENAFIL CITRATE USP (NON-STERILE DRUG SUBSTANCE)
08 1SILDENAFIL CITRATE USP [ROUTE CODE - "SE"]
09 1Sildenafil Citrate
01 1China
02 13India
03 1Israel
04 1Mexico
05 1Poland
06 3U.S.A
01 16Active
02 4Inactive
01 11Complete
02 9Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-11
Pay. Date : 2016-06-13
DMF Number : 23930
Submission : 2010-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-29
Pay. Date : 2017-12-11
DMF Number : 17778
Submission : 2004-10-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2013-04-09
DMF Number : 21154
Submission : 2007-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-25
Pay. Date : 2013-11-18
DMF Number : 21619
Submission : 2008-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23705
Submission : 2010-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-02
Pay. Date : 2015-04-07
DMF Number : 24307
Submission : 2010-10-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23067
Submission : 2009-08-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-07-07
DMF Number : 23509
Submission : 2010-02-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22142
Submission : 2008-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19097
Submission : 2006-01-10
Status : Active
Type : II
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