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Sun Pharmaceutical Industries 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 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS), with a corresponding US DMF Number 30175.
Remarkably, this DMF maintains an Active status since its submission on May 31, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on May 04, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II