Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 2Bachem AG
02 1Aspen API
03 1LGM Pharma
04 1Omgene Life Sciences Pvt. Ltd
05 1ALP Pharm
06 2AstraZeneca
07 1BCN Peptides
08 1Chemi SpA
09 1Chinese Peptide Company
10 1Guangzhou Tosun Pharmaceutical
11 1Jin Dun Medical
12 1Piramal Pharma Solutions
13 1Shenzhen JYMed Technology
14 1Sichuan Huiyu Pharmaceutical
01 6China
02 1India
03 1Italy
04 1Netherlands
05 1Spain
06 2Switzerland
07 2U.S.A
08 2United Kingdom
01 5Active
02 1Inactive
03 10Blank
01 2Valid
02 1Withdrawn by Holder
03 13Blank
01 1304MF10160
02 15Blank
01 16Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-12
Pay. Date : 2019-11-29
DMF Number : 34363
Submission : 2019-12-19
Status : Active
Type : II
Certificate Number : R1-CEP 2003-037 - Rev 03
Issue Date : 2020-12-18
Type : Chemical
Substance Number : 1636
Status : Valid
Registration Number : 304MF10160
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2022-12-23
Latest Date of Registration : --
NDC Package Code : 55463-0005
Start Marketing Date : 2003-11-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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 : 35689
Submission : 2024-05-07
Status : Active
Type : II
NDC Package Code : 55463-0005
Start Marketing Date : 2003-11-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31488
Submission : 2017-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31489
Submission : 2017-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29713
Submission : 2015-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17768
Submission : 2004-10-18
Status : Inactive
Type : II
Certificate Number : R1-CEP 2005-276 - Rev 02
Issue Date : 2017-01-31
Type : Chemical
Substance Number : 1636
Status : Withdrawn by Holder
Certificate Number : R1-CEP 2007-183 - Rev 01
Issue Date : 2014-06-12
Type : Chemical
Substance Number : 1636
Status : Valid
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