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 CINACALCET HYDROCHLORIDE, with a corresponding US DMF Number 24297.
Remarkably, this DMF maintains an Active status since its submission on October 29, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 12, 2014, and payment made on May 17, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II