01 1Sun Pharmaceutical Industries Limited
01 1RANOLAZINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-03-27
DMF Number : 31536
Submission : 2017-09-26
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 RANOLAZINE, with a corresponding US DMF Number 31536.
Remarkably, this DMF maintains an Active status since its submission on September 26, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2017, and payment made on March 27, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
