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01 1Alembic Pharmaceuticals Limited

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Looking for Drug Master Files (DMF) for 26833 of Alembic Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 26833 of Alembic Pharmaceuticals Ltd 1

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Alembic Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is DEFERASIROX, with a corresponding US DMF Number 26833.

Remarkably, this DMF maintains an Active status since its submission on February 27, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2017, and payment made on July 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II