01 1Cipla
01 1DARUNAVIR HYDRATE (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-12
Pay. Date : 2025-04-08
DMF Number : 40826
Submission : 2025-01-10
Status : Active
Type : II
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Cipla 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 DARUNAVIR HYDRATE (PROCESS II), with a corresponding US DMF Number 40826.
Remarkably, this DMF maintains an Active status since its submission on January 10, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 12, 2025, and payment made on April 08, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
