01 1Piramal Pharma Solutions
01 1LURASIDONE HYDROCHLORIDE
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-09-24
DMF Number : 29163
Submission : 2015-03-30
Status : Active
Type : II
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Piramal Pharma Ltd, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Piramal's expertise across varied technologies makes them a partner of choice for innovators & generic companies worldwide.
One of their notable products is LURASIDONE HYDROCHLORIDE, with a corresponding US DMF Number 29163.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2015, and payment made on September 24, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
