Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
01 1Farmhispania
02 3Chunghwa Chemical Synthesis & Biotech
03 1Apotex Fermentation Inc.
04 4Biocon
05 2BrightGene Bio-Medical Technology Co.,Ltd
06 1CKD Bio Corporation
07 1Concord Biotech
08 1Enaltec Labs Private Limited
09 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
10 1MSN Laboratories
11 1Natco Pharma
12 1ScinoPharm Taiwan, Ltd
13 1Yacht Bio-Technology
14 1Blank
01 1BULK EVEROLIMUS
02 1DOFETILIDE USP
03 6EVEROLIMUS
04 1EVEROLIMUS (0.2%BHT)
05 1EVEROLIMUS (2% BHT)
06 1EVEROLIMUS (2.0% BHT)
07 1EVEROLIMUS (NON-STERILE API)
08 1EVEROLIMUS (WITH 0.2% BHT)
09 1EVEROLIMUS B02 USP
10 1EVEROLIMUS PRE-MIX USP
11 1EVEROLIMUS PREMIX 2%
12 2EVEROLIMUS USP
13 1EVEROLIMUS USP (WITH 2% BHT)
14 1EVEROLIMUS, NON-STERILE API
01 1Canada
02 4China
03 8India
04 1South Korea
05 1Spain
06 4Taiwan
07 1Blank
01 19Active
02 1Inactive
01 14Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-28
Pay. Date : 2019-12-23
DMF Number : 34295
Submission : 2019-12-20
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-11
Pay. Date : 2013-03-14
DMF Number : 26819
Submission : 2013-02-08
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 : 38111
Submission : 2023-03-10
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-08-05
DMF Number : 27216
Submission : 2013-07-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-05
Pay. Date : 2015-09-22
DMF Number : 29657
Submission : 2015-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-15
Pay. Date : 2015-09-22
DMF Number : 29651
Submission : 2015-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-01
Pay. Date : 2013-06-13
DMF Number : 26350
Submission : 2013-06-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2012-12-11
DMF Number : 26738
Submission : 2012-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-15
Pay. Date : 2015-09-01
DMF Number : 29696
Submission : 2015-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29405
Submission : 2015-06-05
Status : Active
Type : II
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