01 1Intas Pharmaceuticals
01 1LURASIDONE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-04
Pay. Date : 2014-07-08
DMF Number : 28447
Submission : 2014-07-09
Status : Active
Type : II
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Intas Pharmaceuticals 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 LURASIDONE HYDROCHLORIDE, with a corresponding US DMF Number 28447.
Remarkably, this DMF maintains an Active status since its submission on July 09, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2014, and payment made on July 08, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
