Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Ami Lifesciences Private Limited
03 1Alembic Pharmaceuticals Limited
04 1Amoli Organics
05 1Apotex Pharmachem
06 1Aurobindo Pharma Limited
07 1Azico Biophore India Pvt. Ltd
08 2Glenmark Life Sciences
09 1HEC Pharm
10 1HONOUR LAB LTD
11 1Jubilant Generics
12 1Lunan Pharmaceutical
13 2MSN Laboratories
14 1Macleods Pharmaceuticals Limited
15 1Orchid Pharma
16 1Qilu Tianhe Pharmaceutical Co., Ltd.
17 2RANBAXY LABORATORIES LIMITED
18 1SHANDONG LUNING PHARMACEUTICAL CO., LTD
19 1SMS Pharmaceuticals
20 1TOPHARMAN SHANDONG CO LTD
21 1Teva API
22 1Unichem Laboratories Limited
23 1Viatris
24 1Zhejiang Huahai Pharmaceutical
25 1Zhejiang Yongning Pharmaceutical Co., Lt
01 13TADALAFIL
02 1TADALAFIL (NON STERILE BULK) DRUG SUBSTANCE
03 1TADALAFIL NON-STERILE BULK DRUG SUBSTANCE
04 8TADALAFIL USP
05 1TADALAFIL USP (D150 PROCESS)
06 1TADALAFIL USP (NON-STERILE DRUG SUBSTANCE)
07 1TADALAFIL USP [ROUTE CODE - "TD"]
08 1TADALAFIL USP [ROUTE CODE - "TP"]
09 1TADALAFIL-USP
01 1Canada
02 7China
03 17India
04 1Israel
05 1Poland
06 1U.S.A
01 27Active
02 1Inactive
01 19Complete
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 : 2018-03-07
Pay. Date : 2017-11-15
DMF Number : 24590
Submission : 2011-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37995
Submission : 2023-02-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-22
Pay. Date : 2012-11-02
DMF Number : 22707
Submission : 2009-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-09-18
DMF Number : 25694
Submission : 2012-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22530
Submission : 2009-02-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-11-27
DMF Number : 25513
Submission : 2011-11-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20962
Submission : 2007-10-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2014-11-13
DMF Number : 24206
Submission : 2010-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-07-18
DMF Number : 20884
Submission : 2007-09-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-08-27
DMF Number : 20640
Submission : 2007-06-15
Status : Active
Type : II
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