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 1Apicore
05 1BCN Peptides
06 1Chinese Peptide Company
07 4Debiopharm
08 1Guangzhou Tosun Pharmaceutical
09 1Hainan Shuangcheng Pharmaceuticals
10 1Jin Dun Medical
11 1PolyPeptide Group
12 4STERIS Life Sciences
13 1Smaart Pharmaceutticals
14 1Teva Pharmaceutical Industries
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01 4China
02 4India
03 1Israel
04 1Spain
05 6Switzerland
06 4U.S.A
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01 3Active
02 17Blank
01 20Blank
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01 20Blank
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01 1WC-0047a3
02 19Blank
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01 20Blank
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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 11Blank
01 20Blank
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 : 2025-12-31
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39931
Submission : 2024-06-27
Status : Active
Type : II
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 : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE (22.5mg/2mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
Date of Issue : 2020-01-28
Valid Till : 2022-06-27
Written Confirmation Number : WC-0047a3
Address of the Firm :
55
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A Salvacyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Salvacyl, including repackagers and relabelers. The FDA regulates Salvacyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Salvacyl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Salvacyl supplier is an individual or a company that provides Salvacyl active pharmaceutical ingredient (API) or Salvacyl finished formulations upon request. The Salvacyl suppliers may include Salvacyl API manufacturers, exporters, distributors and traders.
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