01 1MSN Laboratories
01 1AFATINIB DIMALEATE MONOHYDRATE (FORM-R)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-17
Pay. Date : 2017-03-24
DMF Number : 31285
Submission : 2016-12-31
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 AFATINIB DIMALEATE MONOHYDRATE (FORM-R), with a corresponding US DMF Number 31285.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 17, 2017, and payment made on March 24, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
