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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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01 1ChemWerth Inc
02 1API Pharma
03 1Alembic Pharmaceuticals Limited
04 1Charioteer
05 1Maithri Drugs
06 1Prajna Generics
07 1SMS Pharmaceuticals
08 1Shouyuan Chemical
09 1Tecoland Corporation
10 1Torrent Pharmaceuticals Limited
11 1Viatris
01 2China
02 1Croatia
03 5India
04 3U.S.A
01 6Active
02 1Inactive
03 4Blank
01 11Blank
01 11Blank
01 1WC-0373
02 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 : 2019-01-07
Pay. Date : 2018-11-06
DMF Number : 33260
Submission : 2018-11-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-19
Pay. Date : 2020-01-13
DMF Number : 34514
Submission : 2020-01-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-30
Pay. Date : 2016-08-05
DMF Number : 30758
Submission : 2016-07-30
Status : Active
Type : II
NDC Package Code : 63310-2500
Start Marketing Date : 2016-07-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (7kg/7kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-19
Pay. Date : 2022-05-31
DMF Number : 35243
Submission : 2020-09-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-12
Pay. Date : 2020-09-29
DMF Number : 35032
Submission : 2020-09-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-30
Pay. Date : 2021-10-28
DMF Number : 36410
Submission : 2021-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34375
Submission : 2019-12-19
Status : Inactive
Type : II
NDC Package Code : 65015-899
Start Marketing Date : 2020-11-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0373
Address of the Firm :
NDC Package Code : 67835-0010
Start Marketing Date : 2013-11-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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