Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1LGM Pharma
03 3Aspen API
04 1Seqens
05 1Cohance Lifesciences
06 2Fareva
07 1Jai Radhe Sales
08 1HRV Global Life Sciences
09 1Bal Pharma
10 1Aspire Lifesciences Pvt Ltd
11 1Bioindustria L.I.M. Spa
12 1Darou Pakhsh Pharma Chem
13 1Erregierre SpA
14 1Globofarm International
15 1Guangzhou Tosun Pharmaceutical
16 1IBI Spa
17 1LifeFirst Pharma
18 1Mankind Pharma
19 2Medilux Laboratories
20 1Medtronic Plc
21 1Novartis Pharmaceuticals Corporation
22 1Piramal Pharma Solutions
23 1Ramdev Chemicals Pvt Ltd
24 1Reine Lifescience
25 3Resolution Chemicals Limited
26 1Resonance Laboratories Pvt. Ltd
27 1SNA Healthcare
28 1Sumitomo Chemical
29 1Symed Labs
30 1Synthetic Molecules Private Limited
31 1Unichem Laboratories Limited
32 1Viatris
33 1Viyash Life Sciences
34 2Blank
01 1China
02 1France
03 18India
04 1Iran
05 3Italy
06 1Japan
07 2Luxembourg
08 3Netherlands
09 1Poland
10 1Switzerland
11 4U.S.A
12 3United Kingdom
13 2Blank
01 17Active
02 7Inactive
03 17Blank
01 6Valid
02 35Blank
01 1220MF10253
02 1230MF10014
03 39Blank
01 1WC-0015
02 1WC-0123
03 1WC-0150
04 1WC-0381
05 1WC-0381n
06 36Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-08
Pay. Date : 2012-12-11
DMF Number : 18014
Submission : 2005-01-20
Status : Active
Type : II
Registration Number : 230MF10014
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2018-01-30
Latest Date of Registration : --
NDC Package Code : 12658-0448
Start Marketing Date : 1977-11-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2019-08-02
Registration Number : 20181018-209-J-161(5)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19, Pelplinska Street. 83-200 Starogard Gdanski, Poland
Available Reg Filing : ASMF, CA |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6421
Submission : 1986-06-18
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-30
DMF Number : 7077
Submission : 1987-07-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-247 - Rev 01
Issue Date : 2020-07-30
Type : Chemical
Substance Number : 653
Status : Valid
NDC Package Code : 51014-7035
Start Marketing Date : 2009-08-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : BR, CA |
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-29
Pay. Date : 2018-11-26
DMF Number : 33302
Submission : 2018-11-09
Status : Active
Type : II
Certificate Number : R0-CEP 2018-280 - Rev 01
Issue Date : 2022-12-15
Type : Chemical
Substance Number : 653
Status : Valid
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-06-29
Registration Number : 20210629-209-J-1043
Manufacturer Name : Cohance Lifesciences Limited
Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, Krishna District-521 175. Andhra Pradesh, India
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-23
Pay. Date : 2013-07-10
DMF Number : 7311
Submission : 1988-02-02
Status : Active
Type : II
Registration Number : 220MF10253
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2008-12-12
Latest Date of Registration : --
NDC Package Code : 46014-1014
Start Marketing Date : 2008-05-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12541
Submission : 1997-04-17
Status : Active
Type : IV
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