Overview

NCM USA LLC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering ZIRCONIUM-89 (ZR-89) OXALATE SOLUTION.

API / Drug Master Files

NCM USA LLC holds 1 active (1 total) FDA Type II Drug Master File — 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.

  • ZIRCONIUM-89 (ZR-89) OXALATE SOLUTIONActive2014-10-27

FDA compliance signals

5 FDA enforcement records linked to this company.

  • 4832017-12-08

    Equipment procedures overall

  • 4832017-12-08

    Proposed changes to existing specs/methods

  • 4832017-12-08

    Written QA procedures established, followed

  • 4832017-12-08

    Supplies adequately controlled

  • 4832017-12-08

    Weight or measurement of each component

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