CHEMWERTH INC

Overview

CHEMWERTH INC is an active pharmaceutical ingredient (API) supplier with 49 active FDA Type II Drug Master Files, covering ABIRATERONE ACETATE; ANAGRELIDE HYDROCHLORIDE MONOHYDRATE; ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE; ARSENIC TRIOXIDE; AZACITIDINE; BOSENTAN, NON-STERILE BULK DRUG SUBSTANCE.

API / Drug Master Files

CHEMWERTH INC holds 49 active (64 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• FOSPHENYTOIN SODIUM USPActive2023-03-20
• ELTROMBOPAG OLAMINEActive2022-08-29
• SPINOSADActive2022-06-01
• METHYLENE BLUE USPActive2022-06-01
• NELARABINEActive2021-07-22
• SELENIOUS ACID USPActive2021-07-02
• LAPATINIB DITOSYLATE MONOHYDRATEActive2021-02-05
• CLEVIDIPINEActive2020-06-01
• MITOMYCINActive2019-11-04
• PENCICLOVIRActive2018-11-07
• ZIPRASIDONE MESILATE TRIHYDRATEActive2018-10-10
• DOFETILIDE USPActive2017-08-10
• ISOPROTERENOL HCL USPActive2016-09-15
• NEPAFENAC, STERILE BULK DRUG SUBSTANCEActive2015-12-29
• SODIUM NITROPRUSSIDEActive2015-09-30

Showing 15 of 64 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to CHEMWERTH INC in our records. PharmaTek screens the full directory against live FDA enforcement data.