Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Sanofi
03 1LGM Pharma
04 1Jai Radhe Sales
05 1HRV Global Life Sciences
06 1Medichem S.A
07 1Octavius Pharma Pvt. Ltd
08 1Tenatra Chemie
09 2APEX HEALTHCARE LIMITED
10 1Alembic Pharmaceuticals Limited
11 1Apotex Inc
12 1Aurobindo Pharma Limited
13 1CSPC Pharmaceutical Group
14 1CTX Lifesciences
15 1Cadila Pharmaceuticals
16 2Chemi SpA
17 1Chongqing Carelife Pharmaceutical
18 1Cipla
19 1DEAFARMA
20 1Gador SA
21 1Gedeon Richter
22 1Globalchem
23 1Globe Quimica Ltda
24 1Guangzhou Tosun Pharmaceutical
25 2Ipca Laboratories
26 1JPN Pharma
27 1Jubilant Generics
28 1Jubilant Pharmova
29 1Lupin Ltd
30 1Minsheng Group Shaoxing Pharmaceutical
31 1Orchid Pharma
32 1RR LIFESCIENCES
33 1Ryoto Fine Co
34 1Shaanxi Hanjiang pharmaceutical Group Co
35 1Signa S.A. de C.V.
36 1Sun Pharmaceutical Industries Limited
37 1Swati Spentose
38 2Teva API
39 1Teva Pharmaceutical Industries
40 1Trifarma
41 2Unipex
42 1Viatris
43 2Blank
01 1Argentina
02 1Brazil
03 1Canada
04 5China
05 3France
06 1Hungary
07 22India
08 3Israel
09 4Italy
10 1Japan
11 1Mexico
12 1Poland
13 1Spain
14 2U.S.A
15 2Blank
01 12Active
02 12Inactive
03 25Blank
01 10Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
04 36Blank
01 1219MF10310
02 1220MF10178
03 1220MF10241
04 1227MF10301
05 1228MF10049
06 1229MF10112
07 43Blank
01 1WC-0015
02 1WC-0023
03 1WC-0074
04 1WC-0091
05 1WC-0092
06 1WC-0144nA2
07 1WC-0168
08 1WC-0409
09 1WC-0409n
10 1WC-236
11 39Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-16
Pay. Date : 2014-11-28
DMF Number : 16962
Submission : 2003-11-17
Status : Active
Type : II
Certificate Number : R1-CEP 2003-273 - Rev 04
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 1564
Status : Valid
Registration Number : 220MF10241
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2008-12-04
Latest Date of Registration : --
NDC Package Code : 12658-0568
Start Marketing Date : 1999-11-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2022-04-18
Registration Number : 20181023-209-J-116(4)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
Available Reg Filing : ASMF, CA |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2004-215 - Rev 04
Issue Date : 2019-01-04
Type : Chemical
Substance Number : 1564
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Certificate Number : R1-CEP 2010-273 - Rev 00
Issue Date : 2016-10-13
Type : Chemical
Substance Number : 1564
Status : Valid
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20704
Submission : 2007-07-11
Status : Active
Type : II
Certificate Number : R1-CEP 2008-230 - Rev 04
Issue Date : 2022-09-14
Type : Chemical
Substance Number : 1564
Status : Valid
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074
Address of the Firm :
NDC Package Code : 65691-0056
Start Marketing Date : 2007-07-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18577
Submission : 2005-06-06
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-189 - Rev 00
Issue Date : 2013-01-29
Type : Chemical
Substance Number : 1564
Status : Withdrawn by EDQM F...
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