BIOSPECTRA

Overview

BIOSPECTRA is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering TROMETHAMINE.

API / Drug Master Files

BIOSPECTRA holds 1 active (2 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.

• TROMETHAMINEActive2017-03-21
• UREA ACTIVE PHARMACEUTICAL INGREDIENTInactive2017-04-24

FDA compliance signals

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