01 1MSN Laboratories
01 1DABRAFENIB MESYLATE (FORM- 1)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-28
Pay. Date : 2025-07-02
DMF Number : 31080
Submission : 2016-11-10
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 DABRAFENIB MESYLATE (FORM- 1), with a corresponding US DMF Number 31080.
Remarkably, this DMF maintains an Active status since its submission on November 10, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2025, and payment made on July 02, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
