ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1HRV Global Life Sciences
03 1Olpha
04 1Amsa Spa
05 1Ash Stevens, Inc.
06 1CPL Sachse
07 1Cipla
08 1Mehta API
09 1Micro Labs Limited
10 1Piramal Pharma Solutions
11 1Torrent Pharmaceuticals Limited
12 1Zydus Lifesciences
13 1Blank
01 1Germany
02 6India
03 1Italy
04 1Latvia
05 3U.S.A
06 1Blank
01 8Active
02 2Inactive
03 3Blank
01 13Blank
01 13Blank
01 1WC-0113
02 1WC-0214
03 11Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16440
Submission : 2003-02-25
Status : Active
Type : II
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17041
Submission : 2003-12-16
Status : Active
Type : II
NDC Package Code : 63818-0425
Start Marketing Date : 2017-07-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38181
Submission : 2023-05-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15971
Submission : 2002-05-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-14
Pay. Date : 2014-06-11
DMF Number : 16531
Submission : 2003-03-30
Status : Active
Type : II
NDC Package Code : 65841-106
Start Marketing Date : 2024-09-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-02
Pay. Date : 2015-06-30
DMF Number : 29475
Submission : 2015-07-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-23
Pay. Date : 2022-06-08
DMF Number : 37180
Submission : 2022-06-01
Status : Active
Type : II
NDC Package Code : 42571-413
Start Marketing Date : 2022-03-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18240
Submission : 2005-02-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16969
Submission : 2003-11-12
Status : Inactive
Type : II
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