ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Almelo
03 1Aurobindo Pharma Limited
04 1Chromo Laboratories
05 1GLAND PHARMA LIMITED
06 1Guangzhou Tosun Pharmaceutical
07 1Jiangsu Nhwa Pharmaceutical
08 1MSN Laboratories
09 1Sun Pharmaceutical Industries Limited
01 2China
02 6India
03 1U.S.A
01 5Active
02 4Blank
01 9Blank
01 9Blank
01 1WC-0383A9
02 1WC-0427
03 7Blank
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 : 2018-11-26
Pay. Date : 2018-10-18
DMF Number : 31477
Submission : 2018-10-10
Status : Active
Type : II
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DMF Review : Reviewed
Rev. Date : 2016-12-07
Pay. Date : 2016-09-29
DMF Number : 31028
Submission : 2016-09-30
Status : Active
Type : II
Date of Issue : 2019-03-05
Valid Till : 2022-03-04
Written Confirmation Number : WC-0427
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-09
Pay. Date : 2020-08-12
DMF Number : 34715
Submission : 2020-03-26
Status : Active
Type : II
Date of Issue : 2021-09-24
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A9
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NDC Package Code : 69766-085
Start Marketing Date : 2020-03-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 37759
Submission : 2023-07-19
Status : Active
Type : II
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DMF Review : Reviewed
Rev. Date : 2023-10-12
Pay. Date : 2023-08-22
DMF Number : 38745
Submission : 2023-08-23
Status : Active
Type : II
NDC Package Code : 59651-877
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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