20
Divis 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 DEXTROMETHORPHAN HYDROBROMIDE USP, with a corresponding US DMF Number 12356.
Remarkably, this DMF maintains an Active status since its submission on February 04, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 09, 2013, and payment made on November 23, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II