01 1Intas Pharmaceuticals
01 1CAPECITABINE USP (PROCESS III)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2019-02-14
DMF Number : 33574
Submission : 2019-03-04
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 CAPECITABINE USP (PROCESS III), with a corresponding US DMF Number 33574.
Remarkably, this DMF maintains an Active status since its submission on March 04, 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
