Chemwerth Inc

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2019-12-27

Pay. Date : 2019-12-20

DMF Number : 20709

Submission : 2007-07-20

Status : Active

Type : II

02

Arsenic Trioxide

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-06

Pay. Date : 2014-04-07

DMF Number : 26075

Submission : 2012-05-18

Status : Active

Type : II

03

Azacitidine

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2023-01-26

Pay. Date : 2022-12-16

DMF Number : 23416

Submission : 2009-12-22

Status : Active

Type : II

04

Bromfenac Sodium (sesquihydrate)

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-17

Pay. Date : 2013-07-09

DMF Number : 24521

Submission : 2011-05-20

Status : Active

Type : II

05

Clevidipine

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2020-08-04

Pay. Date : 2020-06-23

DMF Number : 34556

Submission : 2020-06-01

Status : Active

Type : II

06

Dexmedetomidine Hcl

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-27

Pay. Date : 2012-12-17

DMF Number : 24202

Submission : 2011-12-15

Status : Active

Type : II

07

Dronedarone Hydrochloride Non-steril...

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-01

Pay. Date : 2013-05-07

DMF Number : 26479

Submission : 2013-05-02

Status : Active

Type : II

08

Eltrombopag Olamine

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2022-10-25

Pay. Date : 2022-09-28

DMF Number : 37269

Submission : 2022-08-29

Status : Active

Type : II

09

Epinastine Hcl

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21974

Submission : 2008-12-30

Status : Active

Type : II

10

Esmolol Hcl

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-18

Pay. Date : 2012-12-17

DMF Number : 16053

Submission : 2002-06-27

Status : Active

Type : II