Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Seqens
03 1Jai Radhe Sales
04 1ASolution Pharmaceuticals
05 1AXYNTIS Group
06 1Abbott Laboratories
07 2Apicore LLC
08 1Cilag AG
09 1Corden Pharma Bergamo S.p.A
10 1Piramal Pharma Solutions
11 1Qfine Synthesis
12 1SNA Healthcare
13 1Siegfried AG
14 2Solara Active Pharma Sciences
15 1Speichim Processing
16 1Viatris
01 3France
02 7India
03 1Italy
04 1Poland
05 1Spain
06 2Switzerland
07 3U.S.A
01 3Active
02 4Inactive
03 11Blank
01 2Valid
02 16Blank
01 18Blank
01 1WC-0110
02 1WC-0110a
03 1WC-0294
04 1WC-0294A1
05 14Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Certificate Number : CEP 2022-090 - Rev 00
Issue Date : 2024-08-13
Type : Chemical
Substance Number : 603
Status : Valid
Available Reg Filing : ASMF |
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20126
Submission : 2006-11-16
Status : Inactive
Type : II
NDC Package Code : 65571-0005
Start Marketing Date : 2001-11-16
End Marketing Date : 2027-07-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-12
Pay. Date : 2024-02-26
DMF Number : 33722
Submission : 2019-03-31
Status : Active
Type : II
Certificate Number : CEP 2019-197 - Rev 01
Issue Date : 2024-07-15
Type : Chemical
Substance Number : 603
Status : Valid
Date of Issue : 2021-08-06
Valid Till : 2024-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
NDC Package Code : 72643-028
Start Marketing Date : 2022-03-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-04
Pay. Date : 2015-09-18
DMF Number : 23288
Submission : 2009-11-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15041
Submission : 2000-09-15
Status : Active
Type : II
NDC Package Code : 49964-0032
Start Marketing Date : 2009-09-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6117
Submission : 1985-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4986
Submission : 1983-06-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5754
Submission : 1985-03-20
Status : Inactive
Type : II
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