01 1Kalintis Healthcare
01 1CEVIMELINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-02
Pay. Date : 2023-09-20
DMF Number : 38880
Submission : 2023-09-25
Status : Active
Type : II
20
Kalintis Healthcare Pvt Ltd, 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 38880.
Remarkably, this DMF maintains an Active status since its submission on September 25, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 02, 2023, and payment made on September 20, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
