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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 AFATINIB DIMALEATE, with a corresponding US DMF Number 31848.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 18, 2017, and payment made on June 27, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II