Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 3Chunghwa Chemical Synthesis & Biotech
02 1Fishfa Biogenics
03 1Farmhispania
04 1TAPI Technology & API Services
05 1ACS DOBFAR SPA
06 1Apotex Fermentation Inc.
07 1Astellas Pharma
08 4Biocon
09 1CKD Bio Corporation
10 2Concord Biotech
11 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
12 1Hangzhou Zhongmei Huadong Pharmaceutical
13 1JOYANG LABORATORIES
14 2Lek Pharmaceuticals
15 2Lunan Pharmaceutical
16 1Murli Krishna Pharma
17 1North China Pharmaceutical Huasheng Co Ltd
18 1Wuxi Fortune Pharmaceutical Co., Ltd
19 2Zhejiang Hisun Pharmaceutical
20 1Blank
01 1MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FOR FK506 (TACROLIMUS) OINTMENT FOR CLINICAL SAMPLES IN MUNCHEN, GERMANY
02 6TACROLIMUS
03 1TACROLIMUS (FK506) DRUG SUBSTANCE
04 1TACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)
05 1TACROLIMUS (PROCESS B)
06 1TACROLIMUS (PROCESS II)
07 1TACROLIMUS (PRODUCT CODE 8000255)
08 1TACROLIMUS GRANULES 20% W/W
09 1TACROLIMUS MONOHYDRATE
10 1TACROLIMUS NON STERILE API
11 1TACROLIMUS PELLETS 5.0% W/W
12 1TACROLIMUS SD20
13 9TACROLIMUS USP
14 2TACROLIMUS USP (PROCESS II)
15 1Tacrolimus
01 1Canada
02 9China
03 8India
04 1Israel
05 1Italy
06 1Japan
07 2Slovenia
08 1South Korea
09 1Spain
10 3Taiwan
11 1Blank
01 23Active
02 6Inactive
01 14Complete
02 15Blank
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2016-03-09
DMF Number : 18985
Submission : 2005-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39667
Submission : 2024-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35852
Submission : 2021-04-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-20
Pay. Date : 2014-08-22
DMF Number : 28524
Submission : 2014-08-24
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23213
Submission : 2009-10-26
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38310
Submission : 2023-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16833
Submission : 2003-09-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-30
Pay. Date : 2013-05-17
DMF Number : 18442
Submission : 2005-06-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-16
DMF Number : 18908
Submission : 2005-10-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-28
Pay. Date : 2015-05-05
DMF Number : 19979
Submission : 2006-11-20
Status : Active
Type : II
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