Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1LGM Pharma
03 1Jai Radhe Sales
04 1Taro Pharmaceutical Industries
05 1Octavius Pharma Pvt. Ltd
06 1AR Life Sciences
07 1Amsa Spa
08 1Angels Pharma India Private Limited
09 1Aspire Lifesciences Pvt Ltd
10 1CHORUS LABS LIMITED
11 1ChemSource
12 1Chemi SpA
13 1Emcure Pharmaceuticals
14 1Fleming Laboratories
15 3Ipca Laboratories
16 1Kreative Organics
17 1Lonza Group
18 1Lonza Inc & Lonza America Inc
19 1Lunan Pharmaceutical
20 1Mitrychem SAS
21 1Mustafa Nevzat Ilac Sanayi A S
22 1Nifty Labs
23 1Nishchem International Pvt. Ltd
24 1PLIVA LACHEMA
25 1Pfizer Inc
26 1Qingdao Qingmei Biotech
27 1Quimica Sintetica
28 1RA CHEM PHARMA LIMITED
29 1RANBAXY LABORATORIES LIMITED
30 1RR LIFESCIENCES
31 1Rumit Group of Companies
32 1Saintsun Pharma
33 1Shamrock Medicaments
34 1Shanvr Life Sciences
35 1Teva API
36 1Teva Pharmaceutical Industries
37 1ULKAR KIMYA SANAYII VE TICARET
38 1Yangzhou Pharmaceutical
39 1Zhejiang Bamboo Pharmaceuticals
40 1Zhejiang chiral Medicine Chemicals Co
41 1Zydus Lifesciences
42 2Blank
01 6China
02 1Croatia
03 1France
04 21India
05 2Israel
06 2Italy
07 1Poland
08 1Spain
09 1Switzerland
10 2Turkey
11 5U.S.A
12 2Blank
01 11Active
02 12Inactive
03 22Blank
01 1Expired
02 8Valid
03 36Blank
01 1225MF10101
02 1227MF10244
03 43Blank
01 1WC-0091
02 1WC-0180
03 1WC-0226
04 1WC-0229
05 41Blank
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 : 11405
Submission : 1995-03-29
Status : Active
Type : II
Certificate Number : R1-CEP 2013-134 - Rev 02
Issue Date : 2023-02-07
Type : Chemical
Substance Number : 1422
Status : Valid
Registration Number : 225MF10101
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2013-05-10
Latest Date of Registration : --
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2020-05-12
Registration Number : 20200324-209-J-453(2)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
Available Reg Filing : EU, CA, BR |
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 15339
Submission : 2001-04-13
Status : Active
Type : II
Certificate Number : R1-CEP 2004-082 - Rev 06
Issue Date : 2023-04-03
Type : Chemical
Substance Number : 1422
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24936
Submission : 2011-05-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-15
Pay. Date : 2017-02-02
DMF Number : 24422
Submission : 2010-12-07
Status : Active
Type : II
Certificate Number : CEP 2014-131 - Rev 01
Issue Date : 2024-08-26
Type : Chemical
Substance Number : 1422
Status : Valid
Date of Issue : 2022-08-29
Valid Till : 2025-07-26
Written Confirmation Number : WC-0180
Address of the Firm :
NDC Package Code : 58793-010
Start Marketing Date : 2016-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5437
Submission : 1984-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14298
Submission : 1999-07-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5795
Submission : 1985-04-10
Status : Inactive
Type : II
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