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Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from WHO-GMP.
One of their notable products is DRONEDARONE HYDROCHLORIDE USP, with a corresponding US DMF Number 27161.
Remarkably, this DMF maintains an Active status since its submission on May 31, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2013, and payment made on May 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II