Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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01 1Bachem AG
02 1Omgene Life Sciences Pvt. Ltd
03 1Sumar Biotech
04 1Cerata Pharmaceuticals LLP
05 1Apicore
06 1BCN Peptides
07 1Chinese Peptide Company
08 4Debiopharm
09 1GenPep Pharmaceuticals
10 1Guangzhou Tosun Pharmaceutical
11 1Hainan Shuangcheng Pharmaceuticals
12 1Jin Dun Medical
13 1PolyPeptide Group
14 4STERIS Life Sciences
15 1Smaart Pharmaceutticals
16 1Teva Pharmaceutical Industries
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01 4China
02 6India
03 1Israel
04 1Spain
05 6Switzerland
06 4U.S.A
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01 3Active
02 19Blank
01 22Blank
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01 22Blank
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01 1WC-0047
02 21Blank
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01 22Blank
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01 155463-0006
02 162788-288
03 162788-437
04 162788-715
05 162788-956
06 171161-103
07 171161-104
08 171161-105
09 171161-106
10 13Blank
01 22Blank
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 : 6291
Submission : 1986-04-25
Status : Active
Type : II
NDC Package Code : 55463-0006
Start Marketing Date : 2006-06-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30364
Submission : 2016-03-11
Status : Active
Type : II
NDC Package Code : 62788-956
Start Marketing Date : 2017-06-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE (22.5mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39931
Submission : 2024-06-27
Status : Active
Type : II



Date of Issue : 2025-10-24
Valid Till : 2028-10-23
Written Confirmation Number : WC-0047
Address of the Firm :


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