01 1Optimus Pharma
01 1LINEZOLID
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-03
Pay. Date : 2021-01-25
DMF Number : 35134
Submission : 2020-12-25
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 LINEZOLID, with a corresponding US DMF Number 35134.
Remarkably, this DMF maintains an Active status since its submission on December 25, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2021, and payment made on January 25, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
