01 1Optimus Pharma
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-09
Pay. Date : 2021-09-16
DMF Number : 36139
Submission : 2021-09-23
Status : Active
Type : II
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Optimus Drugs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is SITAGLIPTIN PHOSPHATE MONOHYDRATE, with a corresponding US DMF Number 36139.
Remarkably, this DMF maintains an Active status since its submission on September 23, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 09, 2021, and payment made on September 16, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
