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 1Apotex Pharmachem
04 1Lupin Ltd
05 1Macleods Pharmaceuticals Limited
06 1RA CHEM PHARMA LIMITED
07 1Symed Labs
08 1Teva Pharmaceutical Industries
09 1Titan Laboratories
10 1Viatris
11 2Wanbury Limited
12 1Zhejiang Huahai Pharmaceutical
13 1Zim Laboratories
01 1Canada
02 1China
03 8India
04 2Israel
05 1Poland
06 1U.S.A
01 6Active
02 3Inactive
03 5Blank
01 14Blank
01 14Blank
01 1WC-0359
02 13Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-19
Pay. Date : 2016-12-07
DMF Number : 20633
Submission : 2007-06-26
Status : Active
Type : II
NDC Package Code : 12658-0412
Start Marketing Date : 2006-10-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-06
Pay. Date : 2012-11-13
DMF Number : 23312
Submission : 2009-11-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-03
Pay. Date : 2013-09-20
DMF Number : 20401
Submission : 2007-04-02
Status : Active
Type : II
Date of Issue : 2019-05-21
Valid Till : 2022-05-20
Written Confirmation Number : WC-0359
Address of the Firm :
NDC Package Code : 65015-884
Start Marketing Date : 2017-10-02
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21512
Submission : 2008-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30566
Submission : 2016-09-20
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-27
Pay. Date : 2014-01-24
DMF Number : 25721
Submission : 2011-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30112
Submission : 2016-01-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20917
Submission : 2007-09-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23467
Submission : 2010-01-15
Status : Inactive
Type : II
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