Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 3Bachem AG
02 1USV Private Limited
03 1ALP Pharm
04 1Alembic Pharmaceuticals Limited
05 1AmbioPharm
06 1Auro Peptides Limited
07 1BCN Peptides
08 1CBL- Chemical and Biopharmaceutical Laboratories
09 1Chemi SpA
10 1Chengdu Shengnuo Biopharm
11 1Fresenius Kabi AB Brunna
12 1Hainan Shuangcheng Pharmaceuticals
13 2Piramal Pharma Solutions
14 3PolyPeptide Group
15 1ScinoPharm Taiwan, Ltd
16 1Sinopep Pharmaceutical Inc
17 2Sun Pharmaceutical Industries Limited
18 1TAPI Technology & API Services
19 1Viatris
20 1Wockhardt
21 1Blank
01 17OCTREOTIDE ACETATE
02 1OCTREOTIDE ACETATE BY GRANULATION
03 1OCTREOTIDE ACETATE DRUG SUBSTANCE
04 5OCTREOTIDE ACETATE USP
05 1OCTREOTIDE ACETATE USP (PROCESS I)
06 1OCTREOTIDE ACETATE USP (PROCESS-II)
07 1OCTREOTIDE HYDROCHLORIDE
01 4China
02 1Greece
03 6India
04 1Israel
05 1Italy
06 1Spain
07 1Sweden
08 6Switzerland
09 1Taiwan
10 4U.S.A
11 1Blank
01 24Active
02 3Inactive
01 14Complete
02 13Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2014-04-10
DMF Number : 16760
Submission : 2003-08-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-16
Pay. Date : 2013-02-27
DMF Number : 24288
Submission : 2010-11-01
Status : Active
Type : II
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 : 38662
Submission : 2023-10-23
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 34145
Submission : 2019-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18740
Submission : 2005-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19567
Submission : 2006-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14994
Submission : 2000-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17678
Submission : 2004-09-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-27
Pay. Date : 2012-11-09
DMF Number : 17777
Submission : 2004-10-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-07
Pay. Date : 2013-12-09
DMF Number : 27729
Submission : 2013-12-20
Status : Active
Type : II
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