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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 ANAGRELIDE HYDROCHLORIDE USP, with a corresponding US DMF Number 16531.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2014, and payment made on June 11, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II