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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 RIOCIGUAT, with a corresponding US DMF Number 31665.
Remarkably, this DMF maintains an Active status since its submission on June 16, 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 28, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II