01 1Cipla
01 1DIFELIKEFALIN ACETATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-03-28
Pay. Date : 2025-03-12
DMF Number : 37712
Submission : 2023-01-25
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 DIFELIKEFALIN ACETATE, with a corresponding US DMF Number 37712.
Remarkably, this DMF maintains an Active status since its submission on January 25, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 28, 2025, and payment made on March 12, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
