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
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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