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Alkem Laboratories 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 DEXMETHYLPHENIDATE HYDROCHLORIDE, with a corresponding US DMF Number 32902.
Remarkably, this DMF maintains an Active status since its submission on June 23, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 10, 2018, and payment made on June 28, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II