01 1Intas Pharmaceuticals
01 1TIPIRACIL HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2019-02-14
DMF Number : 33578
Submission : 2019-02-19
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 TIPIRACIL HYDROCHLORIDE, with a corresponding US DMF Number 33578.
Remarkably, this DMF maintains an Active status since its submission on February 19, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 12, 2019, and payment made on February 14, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
