01 1Biocon
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-19
Pay. Date : 2023-08-28
DMF Number : 38723
Submission : 2023-08-31
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 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP, with a corresponding US DMF Number 38723.
Remarkably, this DMF maintains an Active status since its submission on August 31, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 19, 2023, and payment made on August 28, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
