01 1Biocon
01 1SITAGLIPTIN HYDROCHLORIDE (ENZYMATIC)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-11
Pay. Date : 2024-03-21
DMF Number : 37684
Submission : 2024-03-22
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 HYDROCHLORIDE (ENZYMATIC), with a corresponding US DMF Number 37684.
Remarkably, this DMF maintains an Active status since its submission on March 22, 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
