Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1ASolution Pharmaceuticals
03 1Transo-Pharm USA LLC
04 1Seqens
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01 6China
02 1France
03 1Germany
04 11India
05 2Italy
06 2South Korea
07 1Spain
08 1Switzerland
09 5U.S.A
10 1United Kingdom
01 5Active
02 7Inactive
03 19Blank
01 9Valid
02 2Withdrawn by Holder
03 20Blank
01 1218MF10529
02 1218MF10683
03 1219MF10087
04 1221MF10007
05 1223MF10043
06 26Blank
01 1WC-0037
02 1WC-0045nA2
03 1WC-0226
04 28Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-14
Pay. Date : 2012-12-18
DMF Number : 11204
Submission : 1994-11-22
Status : Active
Type : II
Certificate Number : CEP 2005-003 - Rev 05
Issue Date : 2024-09-04
Type : Chemical
Substance Number : 1558
Status : Valid
Registration Number : 221MF10007
Registrant's Address : Route du simplon 22, CH-1895 Vionnaz-Switzerland
Initial Date of Registration : 2009-01-13
Latest Date of Registration : --
Registrant Name : Daewon Pharmaceutical Co., Ltd.
Registration Date : 2023-02-15
Registration Number : 20200806-210-J-463(4)
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.
Certificate Number : R0-CEP 2021-363 - Rev 00
Issue Date : 2022-02-08
Type : Chemical
Substance Number : 1558
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27418
Submission : 2013-08-13
Status : Active
Type : II
Certificate Number : CEP 2013-202 - Rev 03
Issue Date : 2024-01-17
Type : Chemical
Substance Number : 1558
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-2019
Start Marketing Date : 2014-06-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Myungmoon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-210-J-630
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Plot Nos 92, 93, 94, 257, 258, 259, IDA, Pashamylaram, Isnapur (V), Patancheru (M), Sangareddy (Dt.) -502319 Telangana, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17850
Submission : 2004-11-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11596
Submission : 1995-07-25
Status : Inactive
Type : II
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