01 1Biocon
01 1REPAGLINIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-30
Pay. Date : 2013-04-17
DMF Number : 18482
Submission : 2005-07-06
Status : Active
Type : II
20
Biocon Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is REPAGLINIDE, with a corresponding US DMF Number 18482.
Remarkably, this DMF maintains an Active status since its submission on July 06, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 30, 2013, and payment made on April 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
