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Hetero Drugs 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 APREMILAST (FORM-B), with a corresponding US DMF Number 32236.
Remarkably, this DMF maintains an Active status since its submission on December 07, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 10, 2018, and payment made on November 30, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II