01 1Biocon
01 1ATORVASTATIN CALCIUM (USP) CRYSTALLINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-18
Pay. Date : 2014-04-15
DMF Number : 25247
Submission : 2011-08-26
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 ATORVASTATIN CALCIUM (USP) CRYSTALLINE, with a corresponding US DMF Number 25247.
Remarkably, this DMF maintains an Active status since its submission on August 26, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 18, 2014, and payment made on April 15, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
