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 1ALP Pharm
09 1ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
10 1Alembic Pharmaceuticals Limited
11 1AmbioPharm
12 1Auro Peptides Limited
13 1Aurobindo Pharma Limited
14 1BCN Peptides
15 1CBL- Chemical and Biopharmaceutical Laboratories
16 1Chemi SpA
17 1Chengdu Shengnuo Biopharm
18 1Fresenius Kabi AB Brunna
19 1Hainan Shuangcheng Pharmaceuticals
20 1Hamari chemicals
21 1Hanways Chempharm
22 1Hybio Pharmaceutical
23 1Jin Dun Medical
24 2Piramal Pharma Solutions
25 3PolyPeptide Group
26 1ScinoPharm Taiwan, Ltd
27 1Shenzhen JYMed Technology
28 1Sinopep Pharmaceutical Inc
29 1Smaart Pharmaceutticals
30 2Sun Pharmaceutical Industries Limited
31 1TAPI Technology & API Services
32 1Tecoland Corporation
33 1Teva Pharmaceutical Industries
34 1Tianish Laboratories
35 1Unipex
36 1Viatris
37 1Wockhardt
38 1Blank
01 9China
02 1France
03 1Greece
04 11India
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 17Blank
01 6Valid
02 38Blank
01 1226MF10055
02 1226MF10062
03 1227MF10055
04 1306MF10083
05 40Blank
01 1WC-0012
02 1WC-0047
03 1WC-0159
04 1WC-0237
05 1WC-0443
06 39Blank
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
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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