01 1Optimus Pharma
01 1APIXABAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-21
Pay. Date : 2022-03-25
DMF Number : 36651
Submission : 2022-03-31
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 APIXABAN, with a corresponding US DMF Number 36651.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 21, 2022, and payment made on March 25, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
