01 1Intas Pharmaceuticals
01 1PACLITAXEL (SEMI SYNTHETIC) USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-03
Pay. Date : 2021-08-30
DMF Number : 36253
Submission : 2021-09-02
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 PACLITAXEL (SEMI SYNTHETIC) USP (PROCESS-II), with a corresponding US DMF Number 36253.
Remarkably, this DMF maintains an Active status since its submission on September 02, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 03, 2021, and payment made on August 30, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
