01 1Biocon
01 1LURASIDONE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-11
Pay. Date : 2024-03-21
DMF Number : 39574
Submission : 2024-03-21
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 LURASIDONE HYDROCHLORIDE, with a corresponding US DMF Number 39574.
Remarkably, this DMF maintains an Active status since its submission on March 21, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 11, 2024, and payment made on March 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
