01 1Chemeca Drugs
01 1FEXOFENADINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-21
Pay. Date : 2022-03-14
DMF Number : 36554
Submission : 2021-12-15
Status : Active
Type : II
20
Chemeca Drugs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is FEXOFENADINE HYDROCHLORIDE USP, with a corresponding US DMF Number 36554.
Remarkably, this DMF maintains an Active status since its submission on December 15, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 21, 2022, and payment made on March 14, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
