01 1Apicore
01 1VOSORITIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-29
Pay. Date : 2025-09-04
DMF Number : 42084
Submission : 2025-07-30
Status : Active
Type : II
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Apicore Llc (a Wholly Owned Sub Of Rk Pharma Inc), based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is VOSORITIDE, with a corresponding US DMF Number 42084.
Remarkably, this DMF maintains an Active status since its submission on July 30, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2025, and payment made on September 04, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
