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 1Octavius Pharma Pvt. Ltd
06 1Atman Pharmaceuticals
07 1Bal Pharma
08 2TAPI Technology & API Services
09 2Abbott Laboratories
10 1Abic Ltd.
11 1Alembic Pharmaceuticals Limited
12 2Amoli Organics
13 1Arevipharma
14 1AstraZeneca
15 2Aurobindo Pharma Limited
16 1Blue Circle Organics
17 1CTX Lifesciences
18 1Cambrex Corporation
19 1Cerata Pharmaceuticals
20 2Changzhou Pharmaceutical Factory
21 1DEAFARMA
22 1Daiichi Sankyo
23 1Flamma SpA
24 2GSK
25 1Harman Finochem
26 1Hexahub Pharmachem
27 1Industriale Chimica
28 1Integrin Life Sciences
29 3Ipca Laboratories
30 1JRC
31 1Macleods Pharmaceuticals Limited
32 1Medimpex
33 1Medinex Laboratories
34 1Nishchem International Pvt. Ltd
35 1Otto Brandes
36 1Pliva Hrvatska
37 1Posh Chemicals P. Ltd
38 1Qingdao Qingmei Biotech
39 1Shreeneel Chemicals
40 1Southwest Synthetic Pharmaceutical
41 1Suzhou Lixin Pharmaceutical
42 1Teva Pharmaceutical Industries
43 1Titan Laboratories
44 3Unichem Laboratories Limited
45 1Unipex
46 1Zhejiang Huahai Pharmaceutical
47 1Zhuhai Rundu Pharmaceutical
48 1Zydus Lifesciences
49 2Blank
01 7China
02 1Croatia
03 2France
04 2Germany
05 29India
06 4Israel
07 3Italy
08 1Japan
09 1Poland
10 4U.S.A
11 4United Kingdom
12 2Blank
01 17Active
02 14Inactive
03 29Blank
01 4Expired
02 19Valid
03 1Withdrawn by Holder
04 36Blank
01 1218MF10520
02 1218MF11020
03 1219MF10334
04 1224MF10171
05 1224MF10214
06 1225MF10021
07 1229MF10218
08 53Blank
01 1WC-0017
02 1WC-0063
03 1WC-0077
04 1WC-0077A3
05 1WC-0081
06 1WC-0084
07 1WC-0091
08 1WC-0097
09 1WC-0279
10 1WC-0468
11 50Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-06
Pay. Date : 2014-12-29
DMF Number : 17599
Submission : 2004-08-12
Status : Active
Type : II
Certificate Number : CEP 2004-058 - Rev 06
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 394
Status : Valid
Registration Number : 218MF11020
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2006-12-28
Latest Date of Registration : --
NDC Package Code : 12658-0405
Start Marketing Date : 1982-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea Ltd.
Registration Date : 2021-05-04
Registration Number : 20180611-209-J-86(3)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
Available Reg Filing : ASMF, CN |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5125
Submission : 1983-11-07
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 2115
Submission : 1973-06-14
Status : Active
Type : II
Certificate Number : R1-CEP 2001-304 - Rev 12
Issue Date : 2022-10-03
Type : Chemical
Substance Number : 394
Status : Valid
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 4028
Submission : 1980-12-10
Status : Active
Type : II
Certificate Number : R1-CEP 2004-149 - Rev 07
Issue Date : 2022-10-03
Type : Chemical
Substance Number : 394
Status : Valid
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21181
Submission : 2007-12-31
Status : Inactive
Type : II
Certificate Number : CEP 2012-250 - Rev 02
Issue Date : 2023-09-20
Type : Chemical
Substance Number : 394
Status : Valid
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