01 1GLAND PHARMA LIMITED
01 1DEXRAZOXANE (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-29
Pay. Date : 2014-02-14
DMF Number : 27826
Submission : 2014-02-04
Status : Active
Type : II
20
Gland Pharma 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 DEXRAZOXANE (PROCESS-II), with a corresponding US DMF Number 27826.
Remarkably, this DMF maintains an Active status since its submission on February 04, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2014, and payment made on February 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
