01 1Biocon
01 1ORLISTAT USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-20
Pay. Date : 2023-05-11
DMF Number : 38096
Submission : 2023-04-12
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 ORLISTAT USP, with a corresponding US DMF Number 38096.
Remarkably, this DMF maintains an Active status since its submission on April 12, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 20, 2023, and payment made on May 11, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
