Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Taro Pharmaceutical Industries
03 1Amsa Spa
04 1ChemSource
05 1Chemi SpA
06 1Emcure Pharmaceuticals
07 1Fleming Laboratories
08 3Ipca Laboratories
09 1Kreative Organics
10 1Lonza Group
11 1Lonza Inc & Lonza America Inc
12 1Pfizer Inc
13 1Quimica Sintetica
14 1RANBAXY LABORATORIES LIMITED
15 1Teva API
16 1ULKAR KIMYA SANAYII VE TICARET
17 1Yangzhou Pharmaceutical
18 1Zhejiang chiral Medicine Chemicals Co
19 1Zydus Lifesciences
20 2Blank
01 17-ETHYLTRYPTOPHOL (INTERMEDIATE FOR ETODOLAC
02 9ETODOLAC
03 1ETODOLAC (ETODOLIC ACID)
04 2ETODOLAC DRUG SUBSTANCE
05 1ETODOLAC INTERMEDIATES
06 1ETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY
07 5ETODOLAC USP
08 1ETODOLAC USP (ED6 PROCESS)
09 1ETODOLAC USP (ED7 PROCESS)
10 1ETODOLAC USP MICRONIZED
01 2China
02 8India
03 1Israel
04 2Italy
05 1Poland
06 1Spain
07 1Switzerland
08 1Turkey
09 4U.S.A
10 2Blank
01 11Active
02 12Inactive
01 7Complete
02 16Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 11405
Submission : 1995-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15339
Submission : 2001-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11359
Submission : 1995-02-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-03-06
DMF Number : 25808
Submission : 2012-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-07
Pay. Date : 2013-03-18
DMF Number : 24868
Submission : 2011-05-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-15
Pay. Date : 2017-02-02
DMF Number : 24422
Submission : 2010-12-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2012-11-08
DMF Number : 11766
Submission : 1995-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24936
Submission : 2011-05-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-09
Pay. Date : 2015-03-04
DMF Number : 16789
Submission : 2003-08-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23688
Submission : 2010-04-05
Status : Active
Type : II
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