Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Aspen API
03 1ChemWerth Inc
04 1LGM Pharma
05 1Inabata France S.A.S
06 1Dr. Reddy's Laboratories
07 1Chunghwa Chemical Synthesis & Biotech
08 1Omgene Life Sciences Pvt. Ltd
09 1ALP Pharm
10 1BCN Peptides
11 1Chengdu Shengnuo Biopharm
12 1Chinese Peptide Company
13 1Ipsen
14 1Jin Dun Medical
15 1Piramal Pharma Solutions
16 1Shenzhen JYMed Technology
17 1Sinopep Pharmaceutical Inc
18 1Smaart Pharmaceutticals
19 1Sun Pharmaceutical Industries Limited
20 1Viatris
01 6China
02 2France
03 4India
04 1Netherlands
05 1Spain
06 1Switzerland
07 1Taiwan
08 4U.S.A
01 7Active
02 1Inactive
03 12Blank
01 20Blank
01 20Blank
01 20Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-04-03
Pay. Date : 2019-02-01
DMF Number : 33336
Submission : 2019-02-08
Status : Active
Type : II
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.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39768
Submission : 2024-06-28
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6264
Start Marketing Date : 2019-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-21
Pay. Date : 2015-09-15
DMF Number : 29693
Submission : 2016-08-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8974
Submission : 1991-02-22
Status : Inactive
Type : II
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