01 1Sun Pharmaceutical Industries Limited
01 1TEMSIROLIMUS
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-01
Pay. Date : 2013-03-15
DMF Number : 26825
Submission : 2013-03-30
Status : Active
Type : II
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Sun Pharmaceutical Industries 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 TEMSIROLIMUS, with a corresponding US DMF Number 26825.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 01, 2013, and payment made on March 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
