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 1AR Life Sciences
06 1Amsa Spa
07 1Angels Pharma India Private Limited
08 1Aspire Lifesciences Pvt Ltd
09 1CHORUS LABS LIMITED
10 1ChemSource
11 1Chemi SpA
12 1Emcure Pharmaceuticals
13 1Fleming Laboratories
14 3Ipca Laboratories
15 1Kreative Organics
16 1Lonza Group
17 1Lunan Pharmaceutical
18 1Mitrychem SAS
19 1Mustafa Nevzat Ilac Sanayi A S
20 1Nifty Labs
21 1Nishchem International Pvt. Ltd
22 1PLIVA LACHEMA
23 1Pfizer Inc
24 1Qingdao Qingmei Biotech
25 1Quimica Sintetica
26 1RA CHEM PHARMA LIMITED
27 1RANBAXY LABORATORIES LIMITED
28 1RR LIFESCIENCES
29 1Rumit Group of Companies
30 1Saintsun Pharma
31 1Shamrock Medicaments
32 1Shanvr Life Sciences
33 1Teva API
34 1Teva Pharmaceutical Industries
35 1ULKAR KIMYA SANAYII VE TICARET
36 1Yangzhou Pharmaceutical
37 1Zhejiang Bamboo Pharmaceuticals
38 1Zhejiang chiral Medicine Chemicals Co
39 1Zydus Lifesciences
40 2Blank
01 6China
02 1Croatia
03 1France
04 20India
05 2Israel
06 2Italy
07 1Poland
08 1Spain
09 1Switzerland
10 2Turkey
11 4U.S.A
12 2Blank
01 11Active
02 11Inactive
03 21Blank
01 1Expired
02 8Valid
03 34Blank
01 1225MF10101
02 1227MF10244
03 41Blank
01 1WC-0091
02 1WC-0180
03 1WC-0226
04 1WC-0229
05 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 : 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 : 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 : 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 : 2015-03-09
Pay. Date : 2015-03-04
DMF Number : 16789
Submission : 2003-08-25
Status : Active
Type : II
Certificate Number : CEP 2009-338 - Rev 02
Issue Date : 2023-09-27
Type : Chemical
Substance Number : 1422
Status : Valid
NDC Package Code : 67628-1001
Start Marketing Date : 2013-08-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-09-13
Registration Number : 20210913-209-J-1106
Manufacturer Name : Zhejiang Chiral Medicine Chemicals Co., Ltd
Manufacturer Address : Nanyang Economy Development Zone, Xiaoshan, Hangzhou, Zhejiang Province, China
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 : 11359
Submission : 1995-02-20
Status : Active
Type : II
NDC Package Code : 17373-0186
Start Marketing Date : 2017-01-02
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 : 14298
Submission : 1999-07-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21578
Submission : 2008-04-28
Status : Inactive
Type : II
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