Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 3Aspen API
03 1Seqens
04 1Cohance Lifesciences
05 1Erregierre SpA
06 2Fareva
07 1IBI Spa
08 1Mankind Pharma
09 2Medilux Laboratories
10 1Medtronic Plc
11 1Novartis Pharmaceuticals Corporation
12 1Piramal Pharma Solutions
13 3Resolution Chemicals Limited
14 1Sumitomo Chemical
15 1Unichem Laboratories Limited
16 1Viatris
17 1Viyash Life Sciences
18 1Blank
01 1(R)-(-)-BACLOFEN
02 13-(4-CHLOROPHENYL) GLUTARIC ANHYDRIDE
03 11BACLOFEN
04 1BACLOFEN (PROCESS 2)
05 1BACLOFEN RAW MATERIAL
06 5BACLOFEN USP
07 1LIORESAL INTRATHECAL AMPULS/BACLOFEN
08 1PROPRIETARY MEDTRONIC NEUROMODULATION INFORMATION REGARDING LIORESAL® INTRATHECAL (BACLOFEN INJECTION)
09 1R BACLOFEN
10 1R-BACLOFEN
01 1France
02 6India
03 2Italy
04 1Japan
05 2Luxembourg
06 3Netherlands
07 1Poland
08 1Switzerland
09 3U.S.A
10 3United Kingdom
11 1Blank
01 17Active
02 7Inactive
01 10Complete
02 14Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-11
DMF Number : 18014
Submission : 2005-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6421
Submission : 1986-06-18
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-30
DMF Number : 7077
Submission : 1987-07-14
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-29
Pay. Date : 2018-11-26
DMF Number : 33302
Submission : 2018-11-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35224
Submission : 2020-10-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12541
Submission : 1997-04-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20885
Submission : 2007-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-07-10
DMF Number : 7311
Submission : 1988-02-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9643
Submission : 1992-04-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-04
Pay. Date : 2014-03-28
DMF Number : 18220
Submission : 2005-03-30
Status : Active
Type : II
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