01 1Apicore
01 1CEVIMELINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-12
Pay. Date : 2024-08-24
DMF Number : 40223
Submission : 2024-07-23
Status : Active
Type : II
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Apicore Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is CEVIMELINE HYDROCHLORIDE USP, with a corresponding US DMF Number 40223.
Remarkably, this DMF maintains an Active status since its submission on July 23, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 12, 2024, and payment made on August 24, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
