Synthimed Labs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from EDQM and WHO-GMP.
One of their notable products is ATORVASTATIN CALCIUM USP, with a corresponding US DMF Number 22310.
Remarkably, this DMF maintains an Active status since its submission on December 10, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 06, 2014, and payment made on December 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II