Overview

BIOCHEM OSS BV is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering HEPARIN SODIUM PORCINE; HEPARIN SODIUM USP.

API / Drug Master Files

BIOCHEM OSS BV holds 2 active (3 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.

  • HEPARIN SODIUM PORCINEActive2021-09-22
  • HEPARIN SODIUM USPActive1991-05-09
  • DANAPAROID SODIUMInactive1993-10-08

FDA compliance signals

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

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