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01 1BGG
02 2Cara Partners
03 1Chengdu Chenlv Biological Technology
04 3Dr. Willmar Schwabe Extracta
05 2Euromed SA
06 1Finzelberg GmbH & Co. KG
07 1Hubei Nokete Pharmaceutical
08 2Huisong Pharmaceuticals
09 1Hunan Bitian Technology
10 1Indena
11 1Linnea SA
12 1NINGBO GREEN-HEALTH PHARMACEUTICAL CO LTD
13 1Ningbo Green-Health Pharmaceutical
14 2Shaanxi Jiahe Phytochem
15 1Sichuan Benepure Pharmaceutical
16 1Sichuan Xieli Pharmaceutical
17 1ZHEJIANG CONBA PHARMACEUTICAL CO., LTD. CN 321 109 Lanxi
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01 12China
02 3Denmark
03 1Germany
04 2Ireland
05 1Italy
06 2Spain
07 1Switzerland
08 1U.S.A
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01 1Inactive
02 25Blank
01 1Expired
02 7Valid
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01 120170914-16-K-2-01
02 120171110-16-K-5-01
03 120171129-16-K-11-02
04 120171227-16-K-27-04
05 120171227-16-K-27-04(1)
06 120180918-16-K-42-05
07 120180918-16-K-42-05(1)
08 120181005-16-K-43-06
09 120181005-16-K-43-06(1)
10 120181016-16-K-44-07
11 120181109-16-K-45-08
12 120201021-16-K-56-09
13 120201021-16-K-56-09(1)
14 120201021-16-K-56-09(2)
15 120201030-16-K-57-10
16 120211228-16-K-67-11
17 120250218-16-K-84-12
18 120250403-16-K-85-13
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12477
Submission : 1997-04-22
Status : Inactive
Type : II
Registrant Name : Hanwha Pharmaceutical Co., Ltd.
Registration Date : 2018-11-22
Registration Number : 20181005-16-K-43-06(1)
Manufacturer Name : Cara Partners
Manufacturer Address : Wallingstown, Little Island Industrial Estate, Co. Cork, Ireland
Certificate Number : CEP 2010-220 - Rev 01
Issue Date : 2024-11-27
Type : Herbal
Substance Number : 1827
Status : Valid
Certificate Number : R0-CEP 2021-336 - Rev 01
Issue Date : 2022-03-04
Type : Herbal
Substance Number : 1827
Status : Valid
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2025-04-03
Registration Number : 20250403-16-K-85-13
Manufacturer Name : Euromed SA
Manufacturer Address : Pol Ind Can Magarola, Calle Del Rec De Dalt 21-23, Mollet Del Valles, 08100, Spain
Certificate Number : R1-CEP 2012-267 - Rev 00
Issue Date : 2018-08-27
Type : Herbal
Substance Number : 1827
Status : Valid
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2017-11-29
Registration Number : 20171129-16-K-11-02
Manufacturer Name : Indena SAS
Manufacturer Address : 38, Avenue Gustave Eiffel BP9528, 37095, TOURS CEDEX 2, FRANCE
Certificate Number : R1-CEP 2014-345 - Rev 01
Issue Date : 2022-03-04
Type : Herbal
Substance Number : 1827
Status : Valid
Certificate Number : R1-CEP 2014-066 - Rev 00
Issue Date : 2020-04-23
Type : Herbal
Substance Number : 1827
Status : Valid
Registrant Name : Poonglim Pharmaceutical Co., Ltd.
Registration Date : 2018-10-16
Registration Number : 20181016-16-K-44-07
Manufacturer Name : Ningbo Green-Health Pharmaceutical Co.,Ltd.
Manufacturer Address : Fenghua Xiwu Town Foreign Technological Garden, Ningbo, Zhejiang, China
Certificate Number : R1-CEP 2012-257 - Rev 00
Issue Date : 2019-05-13
Type : Herbal
Substance Number : 1827
Status : Valid
Certificate Number : R1-CEP 2013-116 - Rev 00
Issue Date : 2019-03-27
Type : Herbal
Substance Number : 1827
Status : Valid
Registrant Name : Hanwha Pharmaceutical Co., Ltd.
Registration Date : 2018-11-27
Registration Number : 20180918-16-K-42-05(1)
Manufacturer Name : Schwabe Extracta GmbH & Co. K.G.
Manufacturer Address : Willmar-Schwabe-Str. 4, 76227 Karlsruhe, Germany
Certificate Number : R0-CEP 2011-218 - Rev 00
Issue Date : 2013-06-28
Type : Herbal
Substance Number : 1827
Status : Expired
38
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