DAEWOONG BIO INC

Overview

DAEWOONG BIO INC is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering URSODIOL USP (PROCESS I); URSODIOL USP (PROCESS IV).

Core services & business areas

API / Drug Master Files

DAEWOONG BIO INC holds 2 active (7 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.

• URSODIOL USP (PROCESS IV)Active2015-02-10
• URSODIOL USP (PROCESS I)Active2011-11-16
• STERILE MEROPENEM FOR INFECTIONInactive2012-10-08
• STERILE MEROPENEMInactive2012-01-05
• IOPROMIDEInactive2012-01-05
• URSODIOL USP (URSODEOXYCHOLIC ACID)Inactive2008-03-17
• AMOXICILLINInactive1998-09-01

FDA compliance signals

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