ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1HRV Global Life Sciences
03 1AstraZeneca
04 1Aurobindo Pharma Limited
05 1Beijing Sciecure Pharmaceutical
06 1Chia Tai Tianqing Pharmaceutical Group
07 2Emcure Pharmaceuticals
08 1GLAND PHARMA LIMITED
09 1Guangzhou Tosun Pharmaceutical
10 1Lianyungang Runzhong Pharmaceutical Co Ltd
11 1Maithri Drugs
12 1Trifarma
01 3China
02 6India
03 1Italy
04 2U.S.A
05 1United Kingdom
01 8Active
02 2Inactive
03 3Blank
01 4Valid
02 9Blank
01 13Blank
01 1WC-0226
02 1WC-0226A6
03 1WC-0427A3-4
04 10Blank
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 : 2015-07-10
Pay. Date : 2015-02-05
DMF Number : 28996
Submission : 2015-01-30
Status : Active
Type : II
Certificate Number : R0-CEP 2020-337 - Rev 00
Issue Date : 2023-02-14
Type : Chemical
Substance Number : 1520
Status : Valid
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-31
Pay. Date : 2019-07-05
DMF Number : 32652
Submission : 2018-03-30
Status : Active
Type : II
Certificate Number : R0-CEP 2021-342 - Rev 01
Issue Date : 2023-05-22
Type : Chemical
Substance Number : 1520
Status : Valid
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-925
Start Marketing Date : 2023-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-01-08
Pay. Date : 2015-09-28
DMF Number : 29814
Submission : 2015-09-28
Status : Active
Type : II
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-03
Pay. Date : 2019-08-27
DMF Number : 33288
Submission : 2019-08-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34968
Submission : 2020-07-04
Status : Active
Type : II
Certificate Number : R0-CEP 2020-218 - Rev 00
Issue Date : 2022-05-19
Type : Chemical
Substance Number : 1520
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-20
Pay. Date : 2015-03-11
DMF Number : 29056
Submission : 2015-02-05
Status : Active
Type : II
Certificate Number : R1-CEP 2017-137 - Rev 00
Issue Date : 2023-07-27
Type : Chemical
Substance Number : 1520
Status : Valid
NDC Package Code : 61662-0001
Start Marketing Date : 2014-01-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-18
Pay. Date : 2013-09-12
DMF Number : 19085
Submission : 2006-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6036
Submission : 1985-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11385
Submission : 1995-03-15
Status : Inactive
Type : II
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