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Aurobindo Pharma 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 AMLODIPINE BESYLATE USP, with a corresponding US DMF Number 18965.
Remarkably, this DMF maintains an Active status since its submission on November 09, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2013, and payment made on December 17, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II