Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1TAPI Technology & API Services
03 1ALP Pharm
04 1AmbioPharm
05 1Chengdu Shengnuo Biopharm
06 1Hainan Shuangcheng Pharmaceuticals
07 1Hybio Pharmaceutical
08 2PolyPeptide Group
09 1SHENZHEN SALUBRIS PHARMACEUTICALS
10 1ScinoPharm Taiwan, Ltd
11 2Sinopep Pharmaceutical Inc
12 1Sun Pharmaceutical Industries Limited
01 8BIVALIRUDIN
02 1BIVALIRUDIN (NON-STERILE BULK DRUG)
03 1BIVALIRUDIN (PROCESS II)
04 1BIVALIRUDIN (TM-001-2G)
05 2BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE
06 1HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT
01 7China
02 1India
03 1Israel
04 3Switzerland
05 1Taiwan
06 1U.S.A
01 12Active
02 2Inactive
01 7Complete
02 7Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31458
Submission : 2017-03-31
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 20863
Submission : 2007-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24257
Submission : 2010-09-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-30
Pay. Date : 2013-05-16
DMF Number : 20853
Submission : 2007-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-18
Pay. Date : 2013-08-13
DMF Number : 25531
Submission : 2012-05-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2016-01-14
DMF Number : 30071
Submission : 2016-01-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12797
Submission : 1997-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28912
Submission : 2014-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-16
Pay. Date : 2015-08-20
DMF Number : 25634
Submission : 2011-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24423
Submission : 2011-01-15
Status : Active
Type : II
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