01 1Exemed Pharmaceuticals
01 1DEXTROMETHORPHAN HYDROBROMIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-26
Pay. Date : 2025-06-03
DMF Number : 36112
Submission : 2021-07-26
Status : Active
Type : II
20
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 DEXTROMETHORPHAN HYDROBROMIDE USP, with a corresponding US DMF Number 36112.
Remarkably, this DMF maintains an Active status since its submission on July 26, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 26, 2025, and payment made on June 03, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
