Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1HRV Global Life Sciences
03 1Omgene Life Sciences Pvt. Ltd
04 1Amphastar Pharmaceuticals
05 1Auro Peptides Limited
06 1Aurobindo Pharma Limited
07 1BCN Peptides
08 1Hainan Shuangcheng Pharmaceuticals
09 1Jin Dun Medical
10 1Pfizer Inc
11 1Piramal Pharma Solutions
12 2PolyPeptide Group
13 1Shenzhen JYMed Technology
14 1Xian Harmonious Natural Bio-Techology
01 4China
02 4India
03 1Spain
04 3Switzerland
05 3U.S.A
01 7Active
02 2Inactive
03 6Blank
01 15Blank
01 15Blank
01 15Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-29
Pay. Date : 2017-08-24
DMF Number : 28532
Submission : 2014-08-01
Status : Active
Type : II
NDC Package Code : 52416-127
Start Marketing Date : 2019-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-06
Pay. Date : 2017-11-27
DMF Number : 32146
Submission : 2017-10-12
Status : Active
Type : II
NDC Package Code : 41701-008
Start Marketing Date : 2016-03-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.3g/.3g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-11
Pay. Date : 2018-08-27
DMF Number : 33119
Submission : 2018-08-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25736
Submission : 2012-01-24
Status : Active
Type : II
NDC Package Code : 35207-0005
Start Marketing Date : 2012-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-02
Pay. Date : 2017-10-04
DMF Number : 32116
Submission : 2017-10-03
Status : Active
Type : II
NDC Package Code : 63586-0004
Start Marketing Date : 2023-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-19
Pay. Date : 2022-11-25
DMF Number : 37634
Submission : 2022-12-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5410
Submission : 1984-04-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27577
Submission : 2013-12-19
Status : Inactive
Type : II
NDC Package Code : 63586-0004
Start Marketing Date : 2023-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
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