ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1LGM Pharma
04 1Bachem AG
05 1HRV Global Life Sciences
06 1USV Private Limited
07 1Alembic Pharmaceuticals Limited
08 1AmbioPharm
09 1Auro Peptides Limited
10 1Aurobindo Pharma Limited
11 1Azico Biophore India Pvt. Ltd
12 1BCN Peptides
13 1Chengdu Shengnuo Biopharm
14 1Cipla
15 1Fresenius Kabi AB Brunna
16 1Guangzhou Tosun Pharmaceutical
17 1Hansoh Pharma
18 1MSN Laboratories
19 1Shenzhen JYMed Technology
20 1Smaart Pharmaceutticals
21 1Sun Pharmaceutical Industries Limited
22 1TAPI Technology & API Services
23 1Tecoland Corporation
24 1Teva Pharmaceutical Industries
25 1Viatris
26 1Yonsung Fine Chemicals
01 4China
02 11India
03 2Israel
04 1South Korea
05 1Spain
06 1Sweden
07 1Switzerland
08 5U.S.A
01 15Active
02 11Blank
01 26Blank
01 1229MF10071
02 25Blank
01 1WC-0383A4
02 1WC-0404A3
03 24Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-21
Pay. Date : 2016-09-27
DMF Number : 30526
Submission : 2016-09-27
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : 20862
Submission : 2007-09-17
Status : Active
Type : II
Registration Number : 229MF10071
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2017-04-04
Latest Date of Registration : --
NDC Package Code : 55463-0033
Start Marketing Date : 2007-09-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-08
Pay. Date : 2018-12-03
DMF Number : 33212
Submission : 2018-12-07
Status : Active
Type : II
NDC Package Code : 62147-0277
Start Marketing Date : 2019-12-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-19
Pay. Date : 2019-04-02
DMF Number : 33750
Submission : 2019-04-03
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-24
Pay. Date : 2018-08-13
DMF Number : 31260
Submission : 2016-12-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-27
Pay. Date : 2020-08-12
DMF Number : 30672
Submission : 2016-07-25
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 69766-014
Start Marketing Date : 2016-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-07-10
Pay. Date : 2024-05-21
DMF Number : 38190
Submission : 2024-06-24
Status : Active
Type : II
NDC Package Code : 66558-0197
Start Marketing Date : 2024-01-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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