CAMBRIDGE ISOTOPE LABORATORIES INC

Overview

CAMBRIDGE ISOTOPE LABORATORIES INC is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering 13C UREA; 2-13C URACIL.

Core services & business areas

Pharmaceutical Manufacturing

API / Drug Master Files

CAMBRIDGE ISOTOPE LABORATORIES INC 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.

  • 2-13C URACILActive2004-11-18
  • 13C UREAActive1995-03-16
  • OXYGEN-18 ENRICHED WATER, CIL PART NUMBER OLM-240Inactive2004-05-26

FDA compliance signals

4 FDA enforcement records linked to this company.

  • 4832020-12-09

    Adequate controls (general)

  • 4832020-12-09

    Written specifications - containers and closures

  • 4832020-12-09

    Suitable for intended use

  • 4832020-12-09

    Determination need for investigation

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