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 2Fareva
06 1Erregierre SpA
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
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 :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6421
Submission : 1986-06-18
Status :
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 :
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 :
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-07-10
DMF Number : 7311
Submission : 1988-02-02
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35224
Submission : 2020-10-16
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12541
Submission : 1997-04-17
Status :
Type : IV
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20885
Submission : 2007-09-25
Status :
Type : II
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