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Arch Pharmalabs 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 PIROXICAM USP, with a corresponding US DMF Number 9118.
Remarkably, this DMF maintains an Active status since its submission on May 13, 1991, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2013, and payment made on August 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II