SK Life Science, Inc.

Paramus, New Jersey, USA sklifescienceinc.com

Overview

SK Life Science, Inc. is a subsidiary of SK Biopharmaceuticals, focused on developing therapies for neurological disorders. The company is committed to bringing innovative treatments to patients with unmet medical needs.

Therapeutic areas

NeurologyCentral Nervous System Disorders

API / Drug Master Files

SK Life Science, 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.

  • PITAVASTATIN CALCIUMActive2018-01-17
  • ROSUVASTATIN CALCIUMActive2016-12-06
  • CARISBAMAT (RWJ 333369)Inactive2008-10-22

FDA compliance signals

3 FDA enforcement records linked to this company.

  • 4832021-08-11

    Failure to develop written procedures

  • 4832021-08-11

    Late submission of 15-day report

  • 4832021-08-11

    Failure to report non-alert ADEs

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