01 1Optimus Pharma
01 1BEMPEDOIC ACID
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-24
Pay. Date : 2021-06-11
DMF Number : 35956
Submission : 2021-06-11
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 BEMPEDOIC ACID, with a corresponding US DMF Number 35956.
Remarkably, this DMF maintains an Active status since its submission on June 11, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 24, 2021, and payment made on June 11, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
