01 1Biocon
01 1SIMVASTATIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-15
Pay. Date : 2013-03-01
DMF Number : 18449
Submission : 2005-06-23
Status : Active
Type : II
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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 SIMVASTATIN, with a corresponding US DMF Number 18449.
Remarkably, this DMF maintains an Active status since its submission on June 23, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 15, 2013, and payment made on March 01, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
