01 1Glochem Industries
01 1TOLCAPONE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-15
Pay. Date : 2016-09-20
DMF Number : 30498
Submission : 2016-07-19
Status : Active
Type : II
20
Glochem Industries 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 TOLCAPONE USP, with a corresponding US DMF Number 30498.
Remarkably, this DMF maintains an Active status since its submission on July 19, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2016, and payment made on September 20, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
