Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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01 3Bachem AG
02 1Omgene Life Sciences Pvt. Ltd
03 1ChemWerth Inc
04 1LGM Pharma
05 1HRV Global Life Sciences
06 1TAPI Technology & API Services
07 1Beijing Mesochem Technology
08 1ALP Pharm
09 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
10 1Alembic Pharmaceuticals Limited
11 1AmbioPharm
12 1Apicore
13 1Auro Peptides Limited
14 1Aurobindo Pharma Limited
15 1BCN Peptides
16 1CBL- Chemical and Biopharmaceutical Laboratories
17 1Chemi SpA
18 1Chengdu Shengnuo Biopharm
19 1Fresenius Kabi AB Brunna
20 1Hainan Shuangcheng Pharmaceuticals
21 1Hamari chemicals
22 1Hanways Chempharm
23 1Hybio Pharmaceutical
24 1Jiangsu Sinopep Allsino Biopharmaceutical
25 1Jin Dun Medical
26 2Piramal Pharma Solutions
27 3PolyPeptide Group
28 1ScinoPharm Taiwan, Ltd
29 1Shenzhen JYMed Technology
30 1Shilpa Medicare
31 1Smaart Pharmaceutticals
32 2Sun Pharmaceutical Industries Limited
33 1Suzhou Tianma Pharma Group Co Ltd
34 1Tecoland Corporation
35 1Teva Pharmaceutical Industries
36 1Tianish Laboratories
37 1USV Private Limited
38 1Unipex
39 1Viatris
40 1Vtides Life Sciences
41 1Wockhardt
42 1Blank
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01 11China
02 1France
03 1Greece
04 14India
05 2Israel
06 1Italy
07 1Japan
08 1Spain
09 1Sweden
10 6Switzerland
11 1Taiwan
12 7U.S.A
13 1Blank
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01 24Active
02 3Inactive
03 21Blank
01 8Valid
02 40Blank
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01 1226MF10055
02 1226MF10062
03 1227MF10055
04 1306MF10083
05 44Blank
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01 1WC-0012
02 1WC-0047
03 1WC-0159
04 1WC-0237
05 1WC-0443
06 43Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-09
Pay. Date : 2014-04-10
DMF Number : 16760
Submission : 2003-08-13
Status : Active
Type : II
Certificate Number : R0-CEP 2020-229 - Rev 01
Issue Date : 2022-07-18
Type : Chemical
Substance Number : 2414
Status : Valid
Registration Number : 306MF10083
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2024-07-03
Latest Date of Registration :
NDC Package Code : 52416-109
Start Marketing Date : 2018-04-06
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.
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.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-27
Pay. Date : 2012-11-09
DMF Number : 17777
Submission : 2004-10-21
Status : Active
Type : II
Available Reg Filing : ASMF |
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 34145
Submission : 2019-09-27
Status : Active
Type : II
NDC Package Code : 52416-109
Start Marketing Date : 2018-04-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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 : 38662
Submission : 2023-10-23
Status : Active
Type : II
NDC Package Code : 52416-109
Start Marketing Date : 2018-04-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-04
Pay. Date : 2021-11-26
DMF Number : 35816
Submission : 2021-11-26
Status : Active
Type : II
NDC Package Code : 52958-117
Start Marketing Date : 2024-05-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (500g/500g)
Marketing Category : BULK INGREDIENT
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