Tyche Industries Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is PALONOSETRON HYDROCHLORIDE, with a corresponding US DMF Number 29330.
Remarkably, this DMF maintains an Active status since its submission on May 06, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 18, 2015, and payment made on May 05, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II