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PharmaCompass

Looking for Drug Master Files (DMF) for 35075 of Isotopia Molecular Imaging Ltd

Looking for Drug Master Files (DMF) for 35075 of Isotopia Molecular Imaging Ltd 1

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Isotopia Molecular Imaging Ltd, based in Israel, is a pharmaceutical company.

One of their notable products is LUTETIUM CHLORIDE NON CARRIER ADDED (LU 177 N.C.A.) SOLUTION, with a corresponding US DMF Number 35075.

Remarkably, this DMF maintains an Active status since its submission on August 14, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 18, 2024, and payment made on March 13, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II