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 : 2014-10-13

Pay. Date : 2014-08-04

DMF Number : 26894

Submission : 2014-07-30

Status : Active

Type : II

02

Anagrelide Hydrochloride Monohydrate

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 : 16440

Submission : 2003-02-25

Status : Active

Type : II

03

Argatroban Hydrate (non-sterile Bulk...

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 : 2019-12-27

Pay. Date : 2019-12-20

DMF Number : 20709

Submission : 2007-07-20

Status : Active

Type : II

04

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

05

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

06

Bosentan, Non-sterile Bulk Drug Subs...

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 : 2015-09-09

Pay. Date : 2015-03-04

DMF Number : 29001

Submission : 2015-03-03

Status : Active

Type : II

07

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

08

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

09

Clocortolone Pivalate

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 : 2014-10-07

Pay. Date : 2013-12-06

DMF Number : 25138

Submission : 2011-09-09

Status : Active

Type : II

10

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