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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 BUPROPION HYDROCHLORIDE USP, with a corresponding US DMF Number 22064.
Remarkably, this DMF maintains an Active status since its submission on September 26, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 09, 2013, and payment made on December 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II