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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 DULOXETINE HYDROCHLORIDE USP, with a corresponding US DMF Number 23702.
Remarkably, this DMF maintains an Active status since its submission on April 09, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 01, 2015, and payment made on May 13, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II