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

Active ingredients with DMF or CEP filings

Substances for which DAEWOONG BIO INC holds, or has held, a US FDA Drug Master File or an EU CEP. A filing is not proof of current supply. Open any ingredient to see all its holders, CAS number and product patent dates.

API / Drug Master Files

DAEWOONG BIO INC holds 2 active (7 total) FDA Type II Drug Master Files. A Type II DMF is filed with the FDA to support an active ingredient in drug applications; an active filing can be referenced but is not proof of current supply, and inactive filings are historical.

• 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

Registered manufacturing sites (1)

Physical sites registered with the US FDA and resolved to DAEWOONG BIO INC, with any EU/UK GMP documents matched to each site. Headquarters and manufacturing locations can differ.

• Daewoong Bio Inc.
  Hwaseong-si, South Korea · API manufacture

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to DAEWOONG BIO INC in our records. Events are linked by company name and identifier, so this is not proof that none exist; check the FDA's own databases before relying on it.