ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1MSN Laboratories
03 1RANBAXY LABORATORIES LIMITED
04 1Signa S.A. de C.V.
05 1Sms Lifesciences
06 1Sun Pharmaceutical Industries Limited
07 1Unichem Laboratories Limited
01 5India
02 1Mexico
03 1U.S.A
01 3Active
02 3Inactive
03 1Blank
01 7Blank
01 7Blank
01 1WC-0168
02 1WC-0383A6
03 5Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-05
Pay. Date : 2013-11-26
DMF Number : 22033
Submission : 2008-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17978
Submission : 2005-01-06
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-06
Pay. Date : 2019-09-25
DMF Number : 33494
Submission : 2018-12-31
Status : Active
Type : II
Date of Issue : 2020-07-27
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A6
Address of the Firm :
NDC Package Code : 69766-061
Start Marketing Date : 2018-12-31
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 : 27286
Submission : 2013-08-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18934
Submission : 2005-11-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27380
Submission : 2013-12-20
Status : Inactive
Type : II
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