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 TEMOZOLOMIDE USP, with a corresponding US DMF Number 24298.
Remarkably, this DMF maintains an Active status since its submission on December 17, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 04, 2014, and payment made on November 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II