Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1ChemWerth Inc
03 1LGM Pharma
04 1Omgene Life Sciences Pvt. Ltd
05 1TAPI Technology & API Services
06 1ALP Pharm
07 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
08 1AmbioPharm
09 1Chengdu Shengnuo Biopharm
10 1Guangzhou Tosun Pharmaceutical
11 1Hainan Shuangcheng Pharmaceuticals
12 1Hybio Pharmaceutical
13 1Jin Dun Medical
14 2PolyPeptide Group
15 1SHENZHEN SALUBRIS PHARMACEUTICALS
16 1Sajjala Bio Labs
17 1ScinoPharm Taiwan, Ltd
18 1Shenzhen JYMed Technology
19 2Sinopep Pharmaceutical Inc
20 1Smaart Pharmaceutticals
21 1Sun Pharmaceutical Industries Limited
22 1Teva Pharmaceutical Industries
01 11China
02 4India
03 2Israel
04 3Switzerland
05 1Taiwan
06 3U.S.A
01 12Active
02 2Inactive
03 10Blank
01 24Blank
01 24Blank
01 1WC-0159
02 23Blank
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 : 31458
Submission : 2017-03-31
Status : Active
Type : II
NDC Package Code : 55463-0029
Start Marketing Date : 2012-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 20863
Submission : 2007-09-18
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-03
Pay. Date : 2016-03-08
DMF Number : 30215
Submission : 2016-03-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-04
Pay. Date : 2016-01-14
DMF Number : 30071
Submission : 2016-01-26
Status : Active
Type : II
NDC Package Code : 52958-112
Start Marketing Date : 2019-10-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-09-19
DMF Number : 32281
Submission : 2018-06-29
Status : Active
Type : II
NDC Package Code : 76177-001
Start Marketing Date : 2018-01-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24423
Submission : 2011-01-15
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35259
Submission : 2020-09-30
Status : Inactive
Type : II
NDC Package Code : 76177-001
Start Marketing Date : 2018-01-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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