01 1Micro Labs Limited
01 1RUFINAMIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-03
Pay. Date : 2023-04-12
DMF Number : 38182
Submission : 2023-03-23
Status : Active
Type : II
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Micro Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is RUFINAMIDE USP, with a corresponding US DMF Number 38182.
Remarkably, this DMF maintains an Active status since its submission on March 23, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 03, 2023, and payment made on April 12, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
