01 1Biocon
01 1ROSUVASTATIN CALCIUM USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-24
Pay. Date : 2013-11-25
DMF Number : 27675
Submission : 2013-10-08
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 ROSUVASTATIN CALCIUM USP (PROCESS-II), with a corresponding US DMF Number 27675.
Remarkably, this DMF maintains an Active status since its submission on October 08, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 24, 2014, and payment made on November 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
