Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Apicore LLC
04 1Aurobindo Pharma Limited
05 1F.I.S. Fabbrica Italiana Sintetici
06 2MSN Laboratories
07 1Merck Group
08 1Optimus Pharma
09 1Solara Active Pharma Sciences
10 1Zhejiang Huahai Pharmaceutical
11 1Blank
01 1SAFINAMIDE
02 8SAFINAMIDE MESYLATE
03 1SAFINAMIDE MESYLATE (PROCESS-2)
04 2SAFINAMIDE METHANESULFONATE
01 1China
02 1Germany
03 7India
04 1Italy
05 1Poland
06 1Blank
01 11Active
02 1Inactive
01 6Complete
02 6Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34164
Submission : 2019-09-30
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-28
DMF Number : 35201
Submission : 2020-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-26
DMF Number : 34399
Submission : 2020-02-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-14
Pay. Date : 2020-09-09
DMF Number : 35179
Submission : 2020-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32225
Submission : 2018-02-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-15
Pay. Date : 2020-08-12
DMF Number : 34628
Submission : 2020-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33725
Submission : 2019-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-15
Pay. Date : 2020-08-27
DMF Number : 35138
Submission : 2020-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35719
Submission : 2021-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-01
Pay. Date : 2020-09-22
DMF Number : 35096
Submission : 2020-09-01
Status : Active
Type : II
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