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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 DARIFENACIN HYDROBROMIDE, with a corresponding US DMF Number 26138.
Remarkably, this DMF maintains an Active status since its submission on June 27, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2014, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II