01 1Biocon
01 1EVEROLIMUS PREMIX 2%
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-13
Pay. Date : 2021-03-26
DMF Number : 35688
Submission : 2021-04-01
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 EVEROLIMUS PREMIX 2%, with a corresponding US DMF Number 35688.
Remarkably, this DMF maintains an Active status since its submission on April 01, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 13, 2021, and payment made on March 26, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
