Overview

SI GROUP is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering IBUPROFEN; PROPOFOL.

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances SI GROUP is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

SI GROUP holds 2 active (5 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.

  • PROPOFOLActive1995-12-08
  • IBUPROFENActive1984-06-01
  • IBUPROFEN SODIUM DIHYDRATEInactive2010-04-28
  • ALBE-TAB® IBUPROFEN 90Inactive2005-11-21
  • 2,6-DIISOPROPYPHENOL (DIP)Inactive1995-04-04

FDA compliance signals

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

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