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Zydus Lifesciences 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 APIXABAN, with a corresponding US DMF Number 30630.
Remarkably, this DMF maintains an Active status since its submission on July 06, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 19, 2016, and payment made on June 16, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II