Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 3Bachem AG
02 1Omgene Life Sciences Pvt. Ltd
03 1ChemWerth Inc
04 1LGM Pharma
05 1HRV Global Life Sciences
06 1Tofigh Daru
07 1USV Private Limited
08 1TAPI Technology & API Services
09 1ALP Pharm
10 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
11 1Alembic Pharmaceuticals Limited
12 1AmbioPharm
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 1Jin Dun Medical
25 2Piramal Pharma Solutions
26 3PolyPeptide Group
27 1ScinoPharm Taiwan, Ltd
28 1Shenzhen JYMed Technology
29 1Shilpa Medicare
30 1Sinopep Pharmaceutical Inc
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 1Unipex
38 1Viatris
39 1Wockhardt
40 1Blank
01 10China
02 1France
03 1Greece
04 12India
05 1Iran
06 2Israel
07 1Italy
08 1Japan
09 1Spain
10 1Sweden
11 6Switzerland
12 1Taiwan
13 7U.S.A
14 1Blank
01 24Active
02 3Inactive
03 19Blank
01 8Valid
02 38Blank
01 1226MF10055
02 1226MF10062
03 1227MF10055
04 1306MF10083
05 42Blank
01 1WC-0012
02 1WC-0047
03 1WC-0159
04 1WC-0237
05 1WC-0443
06 41Blank
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.
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-16
Pay. Date : 2013-02-27
DMF Number : 24288
Submission : 2010-11-01
Status : Active
Type : II
Date of Issue : 2022-06-27
Valid Till : 2025-06-02
Written Confirmation Number : WC-0012
Address of the Firm :
NDC Package Code : 62147-0206
Start Marketing Date : 2010-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
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
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