01 1Exemed Pharmaceuticals
01 1SERTRALINE HYDROCHLORIDE USP FORM-I
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-05
Pay. Date : 2024-10-21
DMF Number : 40690
Submission : 2024-10-26
Status : Active
Type : II
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Exemed Pharmaceuticals, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is SERTRALINE HYDROCHLORIDE USP FORM-I, with a corresponding US DMF Number 40690.
Remarkably, this DMF maintains an Active status since its submission on October 26, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 05, 2024, and payment made on October 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
