01 1MSN Laboratories
01 1ACALABRUTINIB MALEATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-06-25
Pay. Date : 2024-06-07
DMF Number : 39468
Submission : 2024-03-28
Status : Active
Type : II
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Msn Laboratories Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ACALABRUTINIB MALEATE, with a corresponding US DMF Number 39468.
Remarkably, this DMF maintains an Active status since its submission on March 28, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 25, 2024, and payment made on June 07, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
