Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Omgene Life Sciences Pvt. Ltd
03 1BCN Peptides
04 1Chinese Peptide Company
05 1Debiopharm
06 1Guangzhou Tosun Pharmaceutical
07 1Hainan Shuangcheng Pharmaceuticals
08 1Jin Dun Medical
09 1PolyPeptide Group
10 1Smaart Pharmaceutticals
11 1Teva Pharmaceutical Industries
01 4China
02 2India
03 1Israel
04 1Spain
05 3Switzerland
01 3Active
02 8Blank
01 11Blank
01 11Blank
01 1WC-0047a3
02 10Blank
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 : 30364
Submission : 2016-03-11
Status : Active
Type : II
NDC Package Code : 62788-288
Start Marketing Date : 2001-06-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION (11.25mg/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 : 2020-01-28
Valid Till : 2022-06-27
Written Confirmation Number : WC-0047a3
Address of the Firm :
NDC Package Code : 59149-006
Start Marketing Date : 2023-02-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (500g/500g)
Marketing Category : BULK INGREDIENT
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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