01 1Micro Labs Limited
01 1Mavacamten
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-12-31
Pay. Date : 2025-11-28
DMF Number : 41418
Submission : 2025-05-14
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 Mavacamten, with a corresponding US DMF Number 41418.
Remarkably, this DMF maintains an Active status since its submission on May 14, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 31, 2025, and payment made on November 28, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
