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 1MSN Laboratories
05 1Mallinckrodt Pharmaceuticals
06 3PolyPeptide Group
07 1RANBAXY LABORATORIES LIMITED
01 4EXENATIDE
02 1EXENATIDE (BULK)
03 1EXENATIDE DRUG SUBSTANCE
04 2EXENATIDE USP
05 1EXENDIN-4 ACETATE (EXENATIDE)
01 1China
02 2India
03 1Ireland
04 1Israel
05 4Switzerland
01 8Active
02 1Inactive
01 4Complete
02 5Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-21
Pay. Date : 2013-09-16
DMF Number : 17227
Submission : 2004-03-05
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2013-05-09
DMF Number : 27123
Submission : 2013-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35476
Submission : 2020-12-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17114
Submission : 2004-01-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34566
Submission : 2020-02-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2013-12-13
DMF Number : 27714
Submission : 2014-01-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19646
Submission : 2006-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30924
Submission : 2016-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-04
Pay. Date : 2015-10-07
DMF Number : 29863
Submission : 2015-12-31
Status : Active
Type : II
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