ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 2Bachem AG
03 1GLAND PHARMA LIMITED
04 1Guangzhou Tosun Pharmaceutical
05 1Huzhou Zhanwang Pharmaceutical Co.,Ltd.
06 1Jiangsu Nhwa Pharmaceutical
07 1Johnson & Johnson Innovative Medicine
08 1Medilux Laboratories
09 1Pisgah Labs
10 1Reliable Biopharmaceutical Corporation
11 2Solara Active Pharma Sciences
01 3China
02 4India
03 2Switzerland
04 4U.S.A
01 6Active
02 2Inactive
03 5Blank
01 5Valid
02 1Withdrawn by Holder
03 7Blank
01 13Blank
01 1WC-0294
02 1WC-0294A1
03 11Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-24
Pay. Date : 2013-06-13
DMF Number : 20500
Submission : 2007-04-30
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-16
Pay. Date : 2014-10-14
DMF Number : 20234
Submission : 2007-01-29
Status : Active
Type : II
Certificate Number : R0-CEP 2020-417 - Rev 00
Issue Date : 2022-05-06
Type : Chemical
Substance Number : 1514
Status : Valid
NDC Package Code : 51504-0012
Start Marketing Date : 2007-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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 : 2023-12-12
Pay. Date : 2023-09-22
DMF Number : 38855
Submission : 2023-09-19
Status : Active
Type : II
Certificate Number : CEP 2005-250 - Rev 03
Issue Date : 2024-03-20
Type : Chemical
Substance Number : 1514
Status : Valid
NDC Package Code : 51504-0012
Start Marketing Date : 2007-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27580
Submission : 2013-09-20
Status : Active
Type : II
Certificate Number : CEP 2017-278 - Rev 02
Issue Date : 2024-09-27
Type : Chemical
Substance Number : 1514
Status : Valid
Date of Issue : 2021-08-06
Valid Till : 2024-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-11
Pay. Date : 2020-02-04
DMF Number : 34205
Submission : 2019-09-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-30
DMF Number : 15983
Submission : 2002-05-24
Status : Active
Type : II
Certificate Number : R0-CEP 2020-231 - Rev 01
Issue Date : 2022-05-10
Type : Chemical
Substance Number : 1514
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11229
Submission : 1994-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10635
Submission : 1993-12-17
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-080 - Rev 03
Issue Date : 2017-11-03
Type : Chemical
Substance Number : 1514
Status : Withdrawn by Holder
Date of Issue : 2019-11-07
Valid Till : 2021-03-04
Written Confirmation Number : WC-0294A1
Address of the Firm :
Certificate Number : R1-CEP 2016-298 - Rev 00
Issue Date : 2023-04-21
Type : Chemical
Substance Number : 1514
Status : Valid
NDC Package Code : 63660-0005
Start Marketing Date : 2011-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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