Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1Apotex Pharmachem
03 2Biocon
04 1Chongqing DaXin Pharmaceutical
05 1Concord Biotech
06 1DEAFARMA
07 2Daiichi Sankyo
08 1Guangdong Blue Treasure Pharmaceutical Co. Ltd.
09 1Kyowa Hakko Bio
10 2Lek Pharmaceuticals
11 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
12 1Livzon New North River Pharmaceutical
13 1RANBAXY LABORATORIES LIMITED
14 1TAPI Technology & API Services
15 1Teva Pharmaceutical Industries
16 2Tianwei Biotech Group
17 1Tocopharm Co. Limited
18 1Vitalpharms
19 3Zhejiang Hisun Pharmaceutical
01 1Canada
02 11China
03 4India
04 2Israel
05 1Italy
06 3Japan
07 2Slovenia
08 1Taiwan
01 7Active
02 9Inactive
03 9Blank
01 1Expired
02 8Valid
03 3Withdrawn by Holder
04 13Blank
01 1218MF10474
02 1218MF10727
03 1219MF10113
04 1219MF10201
05 1223MF10038
06 1223MF10039
07 1227MF10144
08 1229MF10176
09 1231MF10011
10 16Blank
01 1WC-0100N1
02 1WC-0109A
03 1WC-0111
04 22Blank
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14235
Submission : 1999-06-24
Status : Active
Type : II
Certificate Number : R1-CEP 2004-168 - Rev 01
Issue Date : 2021-03-04
Type : Chemical and TSE
Substance Number : 2059
Status : Valid
Registration Number : 218MF10474
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2006-04-27
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17023
Submission : 2003-12-11
Status : Active
Type : II
Certificate Number : R1-CEP 2003-101 - Rev 04
Issue Date : 2019-11-05
Type : Chemical
Substance Number : 2059
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-07
Pay. Date : 2014-05-06
DMF Number : 27615
Submission : 2013-10-21
Status : Active
Type : II
NDC Package Code : 58623-0123
Start Marketing Date : 2018-05-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-07
Registration Number : 20220607-70-B-464-09
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20727
Submission : 2007-08-16
Status : Active
Type : II
Certificate Number : R1-CEP 2010-018 - Rev 01
Issue Date : 2017-10-31
Type : Chemical
Substance Number : 2059
Status : Valid
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0004
Start Marketing Date : 2008-11-01
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 : 18580
Submission : 2005-08-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-167 - Rev 00
Issue Date : 2013-08-21
Type : Chemical
Substance Number : 2059
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15922
Submission : 2002-04-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 2003-025 - Rev 00
Issue Date : 2009-04-14
Type : Chemical
Substance Number : 2059
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16204
Submission : 2002-10-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16309
Submission : 2002-12-13
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-009 - Rev 02
Issue Date : 2021-03-17
Type : Chemical
Substance Number : 2059
Status : Valid
Registration Number : 227MF10144
Registrant's Address : 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province, P. R. China 318000
Initial Date of Registration : 2015-05-20
Latest Date of Registration : --
NDC Package Code : 58623-0123
Start Marketing Date : 2018-05-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-07
Registration Number : 20220607-70-B-464-09
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18709
Submission : 2005-08-24
Status : Inactive
Type : II
NDC Package Code : 58623-0123
Start Marketing Date : 2018-05-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-07
Registration Number : 20220607-70-B-464-09
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16975
Submission : 2003-11-20
Status : Inactive
Type : II
Certificate Number : R0-CEP 2005-016 - Rev 02
Issue Date : 2009-11-19
Type : Chemical
Substance Number : 2059
Status : Expired
Registration Number : 219MF10201
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2007-06-13
Latest Date of Registration : --
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